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Quality Assurance Specialist III
2 weeks ago
Company: Integrated Resources, Inc
Job Summary:
This role is integral to the Quality Assurance team, focusing on the evaluation and approval of clinical and commercial documentation. The Quality Assurance Specialist III will ensure compliance with regulatory standards while supporting the Clinical Trial Division (CTD).
Key Responsibilities:
- Maintain adherence to current Good Manufacturing Practices (cGMP) with an emphasis on patient safety, facilitating the swift introduction of products.
- Utilize comprehensive knowledge of industry regulations and processes to meticulously assess the safety, identity, strength, purity, and quality of batch records.
- Collaborate with clients to fully understand their batch review and release requirements, ensuring all regulatory obligations are met.
- Conduct thorough analyses of all inputs involved in the batch creation process, considering factors such as environmental monitoring and analytical results.
- Ensure that any product batches failing to meet in-process and finished product specifications are appropriately quarantined or rejected.
- Engage with Operations and Quality Assurance teams to resolve any batch release quality concerns.
- Identify and communicate batch review issues promptly, recommending solutions when necessary.
- Prioritize batch record evaluations to meet quality objectives efficiently.
- Deliver exceptional internal and external customer service through clear and timely communication.
- Represent the Quality Assurance team in internal meetings as required.
Qualifications:
- A Bachelor’s Degree is required, preferably in a Life Science discipline; 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 those with batch record release experience.
- Detail-oriented with a keen ability to identify errors or deficiencies in documentation.
- Strong communication skills, capable of engaging effectively with colleagues at all levels.
- Familiarity with Quality Systems, including change control and complaint management, is desired, along with knowledge of SAP and Documentum.
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