Operations Support Specialist at SHINE Technologies LLC

Janesville, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

40.0

Posted On

28 Jan, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good Documentation Practices, Good Manufacturing Practices, Organizational Skills, Attention to Detail, Collaboration, Communication Skills, Microsoft Software, Batch Record Review, Quality Systems, Data Integrity, Continuous Improvement, Documentation Support, Logbook Reviews, SOP Updates, Training Documentation, Audit Preparation

Industry

Energy Technology

Description

Description SHINE Technologies is seeking an Operations Support Specialist who will assist the Production and Quality teams with Therapeutics’ production batch documentation. The Operations Support Specialist's primary responsibility and focus is the review of completed batch documentation for completeness, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) compliance. This position requires strong organizational skills, attention to detail, and the ability to collaborate across departments. The base salary range for this position is $25.00 - $40.00 per hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location. Duties and Responsibilities of the Operations Support Specialist: Review executed batch records for accuracy, completeness, and compliance with internal SOPs and cGMP regulations and coordinate corrections between Operations and Quality Assurance departments. Configure and maintain batch dispensing worksheets. Process and manage label requests, ensuring accurate and timely labeling for all batches. Serve as the primary/point person for weekly production batch review, facilitating communication and documentation flow. Collect, organize, and maintain batch data to support production metrics, trending, and investigations. Support logbook reviews to ensure accuracy, completeness, and compliance Provide documentation support to production management, including compiling reports, maintaining databases, and supporting training documentation. Support preparation for audits and inspections by ensuring documentation is complete, properly filed, and readily accessible. Perform documentation updates (e.g. SOPs, Work Instructions, Forms, etc.) to support the corrective and preventive action program as well as continuous improvement projects. Assist with continuous improvement initiatives related to documentation practices, data integrity, and cGMP compliance. Various administrative support tasks as needed. Requirements Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field preferred. 1-2 years Experience in pharmaceutical or therapeutics manufacturing, cGMP compliance, and documentation practices. Familiarity with batch record review, and quality systems. Strong organizational skills and attention to detail. Ability to work collaboratively across departments. Excellent communication skills, both written and verbal. Skilled in Microsoft desktop software. Working Conditions and Physical Effort: Requires frequent leaning, bending, stooping, crouching, grasping, and reaching above the shoulders and below the knees. Moderate physical activity. Requires handling of average weight objects up to 40 pounds or standing and/or walking for more than four (4) hours per day. Fine motor coordination and strong depth perception is beneficial. Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises. Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions. Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship. Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check. SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions. SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Pay Transparency Policy Employee Rights Under the NLRA Equal Opportunity Employment E-Verify

Responsibilities

The Operations Support Specialist will review completed batch documentation for compliance with Good Documentation Practices and Good Manufacturing Practices. They will also coordinate corrections between departments and support documentation for audits and inspections.