Description:
Will serve as Quality Assurance oversight for Quality Control (QC) data, documentation, and projects as well as Validation documentation and projects. The position will also assist with these activities for third party manufacturers. This position works directly with QC, Validation, and Project management to integrate Quality into industrial operations.
Serve as QA reviewer and approver of QC release, stability and raw material data
Serve as QA reviewer and approver of site validation protocols including production equipment, computer systems, laboratory equipment and methods
Review SOPs for accuracy and compliance; draft revisions for updates as necessary.
Review and approve OOS/OOT investigations for raw materials, intermediates and finished product testing.
Review and approve investigations as it related to the execution of the project or validation.
Provide QA reviews and approvals of QC and/or Validation procedures, methods, change controls, CAPAs, deviations, and other documents, as necessary.
Additional Skills & Qualifications:
BS Degree strongly preferred but can consider AS Degree with desired work experience.
7 Years of Pharma Industry experience including time in an analytical laboratory as well as validation procedures, tech transfer, process development, etc. 7 years + preferred
Ideal experience with reviewing validation protocols within production/manufacturing processes. Must have either high level QC Data Review/Investigation experience or actual QA Auditing experience from a pharma company.
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.