At HealthFirst, our relentless dedication to saving lives drives us forward every day. With an impressive track record of approximately 1,000 lives saved annually and a remarkable total of 52,000 lives saved throughout our storied history, we make an undeniable impact. Each life saved is far more than a statistic; it represents the cherished connection between loved ones, family members, and dear friends. We stand resolute in our commitment and determination to make a lasting impact.
JOB OVERVIEW: This position is responsible for assisting the Sr. Manager of QA in the preparing, tracking, maintaining, copying and distribution of various quality reports, logs, records, and databases. Responsible for prioritizing and coordinating change order submissions. Acts as an interface between all functions to ensure the appropriate changes are properly documented and implemented for change order submission and general documentation guidance. The Document Control Coordinator implements changes to change orders including documentation, bill of materials, drawings, routings etc.

SPECIFIC KNOWLEDGE & SKILLS:

• Ability to learn and apply GMP and SOP concepts during day-to-day processes.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Strong understanding Quality Management systems and Regulatory requirements impacting the medical device industry, including ISO 13485 and FDA regulations.
• Ability to work across numerous scientific and management disciplines.
• Good Computer Skills
• Must be knowledgeable of industry documentation types and Good Documentation Practices (GDP).

GENERAL SKILLS & COMPETENCIES:

• Detail-oriented, organized and applies effective time management skills in order to meet all deadlines
• Able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment
• Basic Understanding of current FDA and GMP / GLP regulations
• Oral and Written Communications, Action Oriented; Organization, Teamwork
• Must be able to work independently with minimal supervision and in a team-oriented environment

MINIMUM WORK EXPERIENCE: .

• A minimum of 3 years of Quality Assurance, Document Control, Records Management and Archiving experience in a biotech or pharmaceutical company
• Experience with electronic change control systems
• Microsoft Suite, proficiency (Microsoft Word, Excel)
• Proficient in Microsoft Office Suite, including Microsoft Word, and Excel
• Strong knowledge of Visio, and Adobe Acrobat

PREFERRED EDUCATION:

• Minimum of High School diploma or GED
• Associate degree in a business or technical discipline or equivalent, preferred

PERFORMANCE REQUIREMENTS:

Typically, to advance to a new job level, TSMs must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations.
The range for this position is $22.50-$30.89. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
BENEFITS: Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Work Life Assistance Program, & Educational Benefits.
HealthFirst is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status

• Reviews change order submissions for completeness, accuracy, reference compliance and process accordingly.
• Identifies gaps in the change order process and makes recommendations for solutions.
• Assist the Sr. Manager of QA in the preparing, tracking, maintaining, copying and distribution of various quality reports, logs, records, and databases.
• Ensures that existing Change Order procedures and Documentation Standards are followed and adhered to.
• Collaborate with departmental managers to ensure that employees receive proper training on new or revised documents. Maintain training records related to document updates and ensure that employees are trained in relevant procedures.
• Collaborate with document owners in creation of training courses, including quizzes. Ensure that training materials are accurate, up-to-date, and aligned with regulatory requirements.
• Assign training courses to employees based on job roles, responsibilities, and training requirements. Track and monitor employee completion status and follow up on overdue training assignments.
• Lead the records management program, including interim and archival activities as well as facilitate shipments to external storage.
• Assist in the management and retention of documentation in accordance with records retention schedules. in conjunction with legal hold notices
• Perform document storage room activities such as filing, organization and, barcoding
• Track document review periods and address with document owners.
• Manages online document repository systems, includes but not limited to all change requests, training, and all other QA/RA activities.
• Assist in the preparation of draft copies for Quality Management System procedures, work instructions, forms, and data, via input from Sr. Manager of QA.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Provide support during internal and external audits, regulatory inspections, and customer audits.
• Assist and participate in internal, and/or regulatory audits.
• Assist the Sr. Manager of QA with documents required to standardize business processes, report results, satisfy regulatory requirements, and communicate with internal and external customers.
• Understand & apply documented departmental Quality Assurance/Regulatory Affairs procedures and instructions, as well as company-wide SOPs, in execution of daily activities.
• Other activities as assigned by the Sr. Manager of QA/RA.
• Support other departmental personnel with various administrative duties, data entry, document preparation, inspection, complaint investigation, etc. as assigned.
• Other activities as assigned by the Manager of QA/RA.