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Quality Document Specialist at Simtra BioPharma Solutions
Bloomington, Indiana, United States - Full Time
Skills Needed
Documentation, Quality Control, Batch Record Review, Regulatory Compliance, Teamwork, Communication, Continuous Improvement, Microsoft Word, Microsoft Excel, Microsoft Outlook, Veeva, Erp Systems, Problem Solving, Customer Service, Attention To Detail, Time Management
Specialization
An associate's degree or two years of relevant experience is required, along with experience in documentation and quality control systems. Proficiency in Microsoft Office and enterprise software is preferred.
FMLA School Psych Immediate Openings! at Clarifi Staffing Solutions
Lombard, Illinois, United States - Full Time
Skills Needed
Psychological Evaluation, Intervention Planning, Consultative Support, Comprehensive Assessments, Counseling, Behavioral Support, Collaboration, Communication, Organizational Skills, Social Skills, Problem Solving, Anger Management, Self Regulation, Self Determination, Optimism
Specialization
A master’s degree in School or Educational Psychology and a valid Illinois Professional Educator License are required. Strong collaboration, communication, and organizational skills are essential, with prior school-based experience preferred.
Experience Required
Minimum 2 year(s)
Illinois Educational Psychologist: Apply Now! at Clarifi Staffing Solutions
Warrenville, Illinois, United States - Full Time
Skills Needed
School Psychology, Testing, Iep Development, Behavioral Frameworks, Health Services, Intervention Systems, Classroom Supports, Emotional Safety, Equitable Learning, Coordination, Evaluation, Planning, Implementation, Support Practices, Independent Functioning
Specialization
Candidates must hold a Master's Degree in School or Educational Psychology and possess a valid school psychology license in Illinois. Eligibility for a state licensing endorsement in School Psychology is also required.
Experience Required
Minimum 2 year(s)
Cybersecurity Analyst Level 1-3 at Capital Staffing Solutions
Gibsonton, FL 33534, USA - Full Time
Skills Needed
Security Tools, Siem, Allen Bradley, Information Systems, Network Security, Computer Science, Security Certification, Mac Os, Bash, Python, Incident Response, Powershell, Ips, Firewalls, It, Patch Management, Endpoint Security
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Class A Route Driver - Req. ID: 3533 at Denali Water Solutions LLC
Fairfield, Connecticut, United States - Full Time
Skills Needed
Class A Cdl License, Tractor Trailer Experience, Safety Management, Customer Communication, Vehicle Operation, Pre Trip Inspections, Basic Repairs, Electronic Logging, Flexibility, Team Collaboration, Problem Solving, Time Management, Physical Stamina, Weather Adaptability, Manual Handling, Record Keeping
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. Additionally, they should have at least 2 years of full-time tractor-trailer experience or equivalent qualifications.
Experience Required
Minimum 2 year(s)
Class A Route Driver - Req. ID: 3527 at Denali Water Solutions LLC
Weedsport, New York, United States - Full Time
Skills Needed
Class A Cdl License, Safe Transportation, Customer Service, Record Keeping, Vehicle Inspections, Communication, Manual Transmission Operation, Electric Pallet Jack Operation, Basic Repairs, Pre Trip Inspections, Post Trip Inspections, Flexible Hours, Safety Regulations, Logistics, Team Collaboration, Environmental Awareness
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. A minimum of 2 years of full-time verifiable tractor-trailer experience is required, or 1 year if a graduate from a Truck Driving School.
Experience Required
Minimum 2 year(s)
Accounting Manager (Not-for-Profit) at Hueman PE Talent Solutions
Chicago, Illinois, USA - Full Time
Skills Needed
Business Process, Microsoft Word, Finance, Communication Skills, Business Units, Outsourcing, Bpo, Business Acumen
Specialization
Accounting, Business, Finance
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Full-Time SLP Wanted! at Clarifi Staffing Solutions
Berwyn, Illinois, United States - Full Time
Skills Needed
Speech Language Pathology, Communication Support, Individualized Education Programs, Therapy, Collaboration, Aac Tools, Visual Supports, Evidence Based Strategies, Documentation, Evaluations, Special Education, Compassion, Teamwork, Low Incidence Disabilities, Profound Disabilities
Specialization
ASHA certification is preferred, and candidates must possess an IL Speech Language Pathology license. A Master's Degree or higher in Speech Language Pathology is required.
Quality Technician - Second Shift at Reader Precision Solutions
Elkhorn, Wisconsin, United States - Full Time
Skills Needed
Quality Inspection, Print Reading, Documentation, Collaboration, Calibration, Quality Procedures, Analytical Skills, Communication Skills, Problem Solving Skills, Attention To Detail, Computer Skills, Teamwork, Mathematics, Gd&T Knowledge, Precision Measuring Tools, Cmm Operation
Specialization
Candidates should have at least 2 years of experience in a quality role, preferably in a machine shop environment, and be proficient in reading technical drawings. Familiarity with precision measuring tools and quality management systems is essential.
Experience Required
Minimum 2 year(s)
Service Technician at Highway Resource Solutions
Bottesford NG13, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Pharmacy Technician - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Interpersonal Skills
Qualification
Graduate
Clinical Pharmacist - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Clinical Pharmacist - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Class A Route Driver - Req. ID: 3540 at Denali Water Solutions LLC
Louisville, Kentucky, United States - Full Time
Skills Needed
Class A Cdl License, Tractor Trailer Experience, Safety Management, Customer Communication, Vehicle Operation, Pre Trip Inspections, Basic Repairs, Electronic Logging, Flexibility, Team Collaboration, Problem Solving, Time Management, Physical Stamina, Attention To Detail, Environmental Awareness, Waste Management
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. Additionally, they should have at least 2 years of full-time verifiable tractor-trailer experience or equivalent qualifications.
Experience Required
Minimum 2 year(s)
Surgery Scheduler at Premier Pain Solutions PLLC
Columbus, North Carolina, United States - Full Time
Skills Needed
Organizational Skills, Communication Skills, Problem Solving Skills, Attention To Detail, Interpersonal Skills, Multitasking, Knowledge Of Medical Terminology, Scheduling, Patient Interaction, Collaboration With Insurance Companies, Administrative Procedures, Ability To Work Under Pressure, Understanding Of Hipaa Guidelines, Ability To Recognize Urgent Situations, Quality Monitoring, Computer Proficiency
Specialization
Candidates must have a high school diploma or GED and at least one year of surgery scheduling or related experience. Strong communication skills and knowledge of medical practice operations are essential for this role.
DIETARY COOK- PRN at COHESIVE STAFFING SOLUTIONS
Prague, Oklahoma, United States - Full Time
Skills Needed
Food Preparation, Sanitation, Teamwork, Communication, Recipe Adherence, Food Safety, Menu Planning, Equipment Maintenance, Adaptability, Interpersonal Skills, Attendance, Hipaa Compliance
Specialization
Candidates must be high school graduates or equivalent, with preferred experience in a kitchen setting. Effective communication and the ability to work independently or as part of a team are essential.
Site Lead - Building Maintenance at Omnia360 Facility Solutions
Columbus, Ohio, United States - Full Time
Skills Needed
Customer Service, General Maintenance, Basic Computer Knowledge, Cmms Software, Safety Classes, Hand Tools, Craft License, Valid Driver's License
Specialization
Candidates must possess outstanding customer service skills and at least 2 years of general maintenance experience. A valid driver's license and the ability to pass background checks and drug screenings are also required.
Experience Required
Minimum 2 year(s)
Site Lead - Building Maintenance at Omnia360 Facility Solutions
Columbus, Ohio, United States - Full Time
Skills Needed
Customer Service, General Maintenance, Electrical Systems, Hvac, Landscaping, Project Management, Cmms Software, Safety Compliance
Specialization
Candidates should possess outstanding customer service skills and at least 2 years of general maintenance experience. A valid driver's license and the ability to pass background checks and drug screenings are also required.
Experience Required
Minimum 2 year(s)
Senior Consultant (Sustainability) at EnviroSolutions Consulting
Singapore, , Singapore - Full Time
Skills Needed
Sensitive Issues, Budgeting, Communication Skills, Project Management Skills, Discretion
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Junior Marketing Coordinator | Mentorship Provided at Phoenix Marketing Solutions
Raffles, , Singapore - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Quality Document Specialist at Simtra BioPharma Solutions
Bloomington, Indiana, United States -
Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

0.0

Posted On

28 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Documentation, Quality Control, Batch Record Review, Regulatory Compliance, Teamwork, Communication, Continuous Improvement, Microsoft Word, Microsoft Excel, Microsoft Outlook, Veeva, ERP Systems, Problem Solving, Customer Service, Attention to Detail, Time Management

Industry

Pharmaceutical Manufacturing

Description
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. The role: The Documentation Specialist is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign-out and sign-in of batch records from the Documentation Center. This role will also be responsible for assisting employees with correction resolution and handling the executed batch record documentation while going through the correction process. This role will also have secondary responsibilities assigned to help manage the work load in the Documentation Centers. These responsibilities could include, batch record review, support section review, non-batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization. The hours for this role are Monday-Friday 11:30p-7:30a The responsibilities: Perform assigned tasks related to Veeva and ERP system for batches. Perform batch record review for GMP support sections produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. Reconcile discrepancies with documentation and/or electronic systems as appropriate. Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record. As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types. Manage the process of sign-out and sign-in of batch records. Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections. Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release. Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction. Qualification Associates degree or 2 years of similar relevant experience Experience with documentation and/or quality control systems preferred Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.) Physical / Safety Requirements: Occasionally required to lift and/or move objects (boxes, totes, etc.) weighing 25 pounds Duties may require nights and weekend work Use of hands and fingers to manipulate office equipment is required Position requires sitting for long hours but may involve walking or standing for periods of time In return, you’ll be eligible for[1]: Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child Life Insurance Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits Voluntary Insurance Benefits Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union [1] Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
Responsibilities
The Quality Document Specialist is responsible for compiling all documentation required for batch manufacturing and managing the sign-out and sign-in of batch records. This role also assists with correction resolution and supports various documentation review processes.
Quality Document Specialist at Simtra BioPharma Solutions
Bloomington, Indiana, United States - Full Time
Skills Needed
Documentation, Quality Control, Batch Record Review, Regulatory Compliance, Teamwork, Communication, Continuous Improvement, Microsoft Word, Microsoft Excel, Microsoft Outlook, Veeva, Erp Systems, Problem Solving, Customer Service, Attention To Detail, Time Management
Specialization
An associate's degree or two years of relevant experience is required, along with experience in documentation and quality control systems. Proficiency in Microsoft Office and enterprise software is preferred.
FMLA School Psych Immediate Openings! at Clarifi Staffing Solutions
Lombard, Illinois, United States - Full Time
Skills Needed
Psychological Evaluation, Intervention Planning, Consultative Support, Comprehensive Assessments, Counseling, Behavioral Support, Collaboration, Communication, Organizational Skills, Social Skills, Problem Solving, Anger Management, Self Regulation, Self Determination, Optimism
Specialization
A master’s degree in School or Educational Psychology and a valid Illinois Professional Educator License are required. Strong collaboration, communication, and organizational skills are essential, with prior school-based experience preferred.
Experience Required
Minimum 2 year(s)
Illinois Educational Psychologist: Apply Now! at Clarifi Staffing Solutions
Warrenville, Illinois, United States - Full Time
Skills Needed
School Psychology, Testing, Iep Development, Behavioral Frameworks, Health Services, Intervention Systems, Classroom Supports, Emotional Safety, Equitable Learning, Coordination, Evaluation, Planning, Implementation, Support Practices, Independent Functioning
Specialization
Candidates must hold a Master's Degree in School or Educational Psychology and possess a valid school psychology license in Illinois. Eligibility for a state licensing endorsement in School Psychology is also required.
Experience Required
Minimum 2 year(s)
Cybersecurity Analyst Level 1-3 at Capital Staffing Solutions
Gibsonton, FL 33534, USA - Full Time
Skills Needed
Security Tools, Siem, Allen Bradley, Information Systems, Network Security, Computer Science, Security Certification, Mac Os, Bash, Python, Incident Response, Powershell, Ips, Firewalls, It, Patch Management, Endpoint Security
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Class A Route Driver - Req. ID: 3533 at Denali Water Solutions LLC
Fairfield, Connecticut, United States - Full Time
Skills Needed
Class A Cdl License, Tractor Trailer Experience, Safety Management, Customer Communication, Vehicle Operation, Pre Trip Inspections, Basic Repairs, Electronic Logging, Flexibility, Team Collaboration, Problem Solving, Time Management, Physical Stamina, Weather Adaptability, Manual Handling, Record Keeping
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. Additionally, they should have at least 2 years of full-time tractor-trailer experience or equivalent qualifications.
Experience Required
Minimum 2 year(s)
Class A Route Driver - Req. ID: 3527 at Denali Water Solutions LLC
Weedsport, New York, United States - Full Time
Skills Needed
Class A Cdl License, Safe Transportation, Customer Service, Record Keeping, Vehicle Inspections, Communication, Manual Transmission Operation, Electric Pallet Jack Operation, Basic Repairs, Pre Trip Inspections, Post Trip Inspections, Flexible Hours, Safety Regulations, Logistics, Team Collaboration, Environmental Awareness
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. A minimum of 2 years of full-time verifiable tractor-trailer experience is required, or 1 year if a graduate from a Truck Driving School.
Experience Required
Minimum 2 year(s)
Accounting Manager (Not-for-Profit) at Hueman PE Talent Solutions
Chicago, Illinois, USA - Full Time
Skills Needed
Business Process, Microsoft Word, Finance, Communication Skills, Business Units, Outsourcing, Bpo, Business Acumen
Specialization
Accounting, Business, Finance
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Full-Time SLP Wanted! at Clarifi Staffing Solutions
Berwyn, Illinois, United States - Full Time
Skills Needed
Speech Language Pathology, Communication Support, Individualized Education Programs, Therapy, Collaboration, Aac Tools, Visual Supports, Evidence Based Strategies, Documentation, Evaluations, Special Education, Compassion, Teamwork, Low Incidence Disabilities, Profound Disabilities
Specialization
ASHA certification is preferred, and candidates must possess an IL Speech Language Pathology license. A Master's Degree or higher in Speech Language Pathology is required.
Quality Technician - Second Shift at Reader Precision Solutions
Elkhorn, Wisconsin, United States - Full Time
Skills Needed
Quality Inspection, Print Reading, Documentation, Collaboration, Calibration, Quality Procedures, Analytical Skills, Communication Skills, Problem Solving Skills, Attention To Detail, Computer Skills, Teamwork, Mathematics, Gd&T Knowledge, Precision Measuring Tools, Cmm Operation
Specialization
Candidates should have at least 2 years of experience in a quality role, preferably in a machine shop environment, and be proficient in reading technical drawings. Familiarity with precision measuring tools and quality management systems is essential.
Experience Required
Minimum 2 year(s)
Service Technician at Highway Resource Solutions
Bottesford NG13, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Pharmacy Technician - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Interpersonal Skills
Qualification
Graduate
Clinical Pharmacist - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Clinical Pharmacist - Remote at Core Prescribing Solutions
United Kingdom, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Class A Route Driver - Req. ID: 3540 at Denali Water Solutions LLC
Louisville, Kentucky, United States - Full Time
Skills Needed
Class A Cdl License, Tractor Trailer Experience, Safety Management, Customer Communication, Vehicle Operation, Pre Trip Inspections, Basic Repairs, Electronic Logging, Flexibility, Team Collaboration, Problem Solving, Time Management, Physical Stamina, Attention To Detail, Environmental Awareness, Waste Management
Specialization
Candidates must possess a Class A CDL License and have a clean driving record. Additionally, they should have at least 2 years of full-time verifiable tractor-trailer experience or equivalent qualifications.
Experience Required
Minimum 2 year(s)
Surgery Scheduler at Premier Pain Solutions PLLC
Columbus, North Carolina, United States - Full Time
Skills Needed
Organizational Skills, Communication Skills, Problem Solving Skills, Attention To Detail, Interpersonal Skills, Multitasking, Knowledge Of Medical Terminology, Scheduling, Patient Interaction, Collaboration With Insurance Companies, Administrative Procedures, Ability To Work Under Pressure, Understanding Of Hipaa Guidelines, Ability To Recognize Urgent Situations, Quality Monitoring, Computer Proficiency
Specialization
Candidates must have a high school diploma or GED and at least one year of surgery scheduling or related experience. Strong communication skills and knowledge of medical practice operations are essential for this role.
DIETARY COOK- PRN at COHESIVE STAFFING SOLUTIONS
Prague, Oklahoma, United States - Full Time
Skills Needed
Food Preparation, Sanitation, Teamwork, Communication, Recipe Adherence, Food Safety, Menu Planning, Equipment Maintenance, Adaptability, Interpersonal Skills, Attendance, Hipaa Compliance
Specialization
Candidates must be high school graduates or equivalent, with preferred experience in a kitchen setting. Effective communication and the ability to work independently or as part of a team are essential.
Site Lead - Building Maintenance at Omnia360 Facility Solutions
Columbus, Ohio, United States - Full Time
Skills Needed
Customer Service, General Maintenance, Basic Computer Knowledge, Cmms Software, Safety Classes, Hand Tools, Craft License, Valid Driver's License
Specialization
Candidates must possess outstanding customer service skills and at least 2 years of general maintenance experience. A valid driver's license and the ability to pass background checks and drug screenings are also required.
Experience Required
Minimum 2 year(s)
Site Lead - Building Maintenance at Omnia360 Facility Solutions
Columbus, Ohio, United States - Full Time
Skills Needed
Customer Service, General Maintenance, Electrical Systems, Hvac, Landscaping, Project Management, Cmms Software, Safety Compliance
Specialization
Candidates should possess outstanding customer service skills and at least 2 years of general maintenance experience. A valid driver's license and the ability to pass background checks and drug screenings are also required.
Experience Required
Minimum 2 year(s)
Senior Consultant (Sustainability) at EnviroSolutions Consulting
Singapore, , Singapore - Full Time
Skills Needed
Sensitive Issues, Budgeting, Communication Skills, Project Management Skills, Discretion
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Junior Marketing Coordinator | Mentorship Provided at Phoenix Marketing Solutions
Raffles, , Singapore - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate