Quality Control Specialist
2 weeks ago
As a key member of our team, you will engage in the formulation, development, execution, and oversight of strategies and practices to guarantee that designated products fulfill predefined specifications, design standards, and regulatory requirements while meeting customer expectations.
Key Responsibilities and Duties
- Assess deviations, non-conformances, customer feedback, and process/product change control for thoroughness and quality impact on existing products.
- Review, advise, and endorse Risk Analysis.
- Act as the Quality representative on product development teams, ensuring adherence to Design Control standards.
- Lead and guide the creation of equipment/product/process Verification & Validation Protocols.
- Examine product release records and documentation for completeness and accuracy in alignment with production timelines.
- Identify essential performance metrics and develop reporting mechanisms.
- Investigate and collaborate with various departments to address quality challenges.
- Drive continuous improvement initiatives and work collaboratively to implement corrective and preventive measures.
- Facilitate Quality system training and contribute to the development of training programs focused on all aspects of producing high-quality products.
- Support audits and inspections.
- Bachelor's Degree in a life science or engineering discipline is required.
- A minimum of 5 years' experience in Quality Assurance, Engineering, or a Scientist role.
- At least 5 years' experience with change control and complex problem-solving.
- A minimum of 3 years of knowledge regarding cGMP regulations (21 CFR 820, ISO 13485).
- Familiarity with cGMP regulations (21 CFR 820, ISO preferred).
- Certification in a quality discipline is preferred, such as CQM, CQA, CQE.
- Proficient in computer skills (Microsoft Windows and Office programs), with familiarity in Oracle preferred.
- Proven problem-solving and analytical capabilities.
Actalent is a prominent global provider of engineering and scientific services and talent solutions.
We empower visionary companies to advance their engineering and science projects by connecting them with specialized experts who drive scale, innovation, and speed to market.
With a network of nearly 30,000 consultants and over 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent collaborates with many Fortune 500 companies.
Diversity, Equity & InclusionAt Actalent, we believe that diversity and inclusion are essential to the equity and success of our workforce.
Our commitment to DE&I is woven into our culture through:
- Recruiting diverse talent
- Fostering an inclusive environment through ongoing self-reflection
- Cultivating a culture of care, engagement, and recognition with clear outcomes
- Providing growth opportunities for our employees
Actalent is an equal opportunity employer and welcomes 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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