Quality Assurance Specialist; batch release

Title: Quality Assurance Specialist (batch release)

Duration: 8-10 months

Rate: $35/hr.

• Comply with cGMP regulations and all standard operating procedures.
• Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures. Provide cGMP guidance as needed.
• Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP.
• Perform timely review of GMP records (Batch Records, Laboratory Records, Notebooks, etc). Work closely with QA management to proactively address the quality of documentation. Review and release components, raw materials, and finished products.
• Create, revise and/or review SOPs, protocols, reports, change controls and other GMP documentation.
• Conduct and/or review complaint, non-conformance, and deviation investigations.
• Support and organize stability studies for finished product.
• Provide assistance in preparation and during internal, customer and agency audits.
• Maintain assigned Quality Systems or processes as assigned. Perform tracking and presenting of quality metrics (KPIs). Work with QA management on continuous improvement of the Quality Systems to ensure compliance with regulatory guidelines.
• Use of electronic QMS and other software as required.
• Other related duties as assigned.

• Bachelor’s degree in a scientific discipline or equivalent (4 years’ experience) in a quality control or quality assurance function associated with manufacturing.
• 2 years’ experience in quality control or quality assurance function associated with manufacturing preferred.
• Experience and knowledge of cGMP regulations (21 CFR 210/211) preferred.
• Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations.
• Strong communication skills, both written and verbal. Ability to multi-task and prioritize tasks as needed.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.

Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.