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Job Description: Our client a global pharma manufacturer is seeking a Manufacturing Quality Assurance Associate to evaluate and review manufacturing activities (incoming material release, batch release, investigations, change controls, other activities as needed) in support of clinical and commercial batch production. Yu will evaluate and review manufacturing activities (incoming material release, batch release, investigations, change controls, other activities as needed) in support of clinical and commercial batch production. Your expertise will help in identifying deviations from established standards, in the manufacturing of clinical and commercial batches. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. In the relevant cases you will approve minor investigations and participate in minor change control activities to ensure compliance to procedures/GMPs.
• Demonstrate sufficient depth of knowledge within your own work area to perform hands-on routine QA tasks.
• Exercise judgement in resolving level appropriate quality issues related to product manufacture and testing with guidance and coaching.
• Contribute to Quality Assurance activities by undertaking a variety of level appropriate assignments. You will perform end to end assignments within Manufacturing Quality Assurance. The assignments include incoming material review/release, batch record review (to include in-process batch record review/QA-on-the-floor activities), minor investigation review/approval and minor change control activities to assurance compliance with regulatory standards and regulatory filing.
Top Skills Details:
biology,chemistry
Quality Assurance
CAPA's, Technical Writing, Investigations
Qualifications:
Technical bachelors degree in a life science field (biology, biochem, microbiology, chemistry, etc..)
Ability to work in a team environment within own team and interdepartmental teams.
Good written and oral communication skills.
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.
