- 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
QA Specialist II - San Mateo, United States - Actalent
Description
Description:
Executes batch record review
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality objectives are met.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviews routine manufacturing, environmental monitoring and quality control data for in process and finished products.
Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May participate in the writing of annual product reviews
May participate in compilation of metrics (e.g. APR, QMR, etc...)
Normally receives very little instruction on routine work, general instructions on new assignments.
Interfaces with contract manufacturers to address documentation and compliance issues.
Perform other work as assigned
May participate in development of training programs regarding all aspects of producing quality products.
Skills:
batch record review, Quality assurance, standard operating procedure, glp, gmp environment
Qualifications:
• 2+ years of experience relevant to job description.
QA / batch record review of aseptic fill pharma products - vials, parenterals
Experience Level:
Intermediate 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:
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.
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