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Quality Control Expert III
2 months ago
Maxonic values its long-standing partnerships with clients and is currently seeking a Quality Specialist III (Medical Device & Manufacturing).
Position Overview:
Job Title: Quality Specialist III (Medical Device & Manufacturing)
Job Type: Contractual Role (with potential for extension and full-time conversion)
Location: Remote opportunities available
Compensation: Competitive hourly rate with benefits
Work Schedule: Monday to Friday (40 hours per week)
Key Responsibilities:
Reporting to the Quality Manager within the Documentation team, this role is essential for the review and approval of clinical and commercial batch records, both paper and electronic.
What You Will Be Responsible For:
- Upholding the principles of current Good Manufacturing Practices (cGMP) with a strong emphasis on patient safety while facilitating the swift introduction of products.
- Utilizing a comprehensive understanding of regulations, product authorizations, and manufacturing processes to meticulously verify all aspects of batch safety, identity, strength, purity, and quality. Collaborating with clients to fully understand their batch review and release requirements.
- Conducting thorough analyses of all inputs involved in the batch creation process, considering factors such as environmental monitoring, analytical results, and maintenance records.
- Ensuring that product batches not meeting the required specifications are appropriately quarantined or rejected to prevent unauthorized use.
- Collaborating with Operations, Quality Assurance, and other internal teams to resolve any batch release quality concerns.
- Proactively identifying potential issues in batch reviews and communicating these effectively to the relevant parties.
- Prioritizing batch record evaluations and client releases to meet operational objectives while maintaining high-quality standards.
- Maintaining excellent internal and external customer service through clear and timely communication.
- Ensuring all quality provisions are met before certifying finished goods for market release.
- Representing the Quality Assurance team in internal meetings as necessary.
Qualifications:
- A Bachelor's Degree is required (preferably in Life Sciences); an advanced degree is advantageous.
- 3-5 years of experience in the pharmaceutical or medical device industry within a GMP environment, with a strong preference for candidates with batch record release experience.
- Detail-oriented with the ability to identify discrepancies in batch records and apply sound judgment in evaluating documentation.
- Strong communication skills to engage effectively with colleagues at various levels.
- Familiarity with Quality Systems (including change control and complaint management) and knowledge of software such as SAP and Trackwise is preferred.
About Maxonic:
Since its inception in 2002, Maxonic has been dedicated to aligning candidate strengths with client needs. Our award-winning team of recruiting professionals specializes in technology and is committed to finding positions that fulfill the long-term career aspirations of our candidates.
