Quality Operations Assessor I
Job Summary:
The Quality Operations Assessor manages quality exceptions such as deviations, events, OOS, NCMRs, CAPA, and any other quality related incident. Approves all product specific master documentation for use in the manufacture and testing of finished drug product.Serves as the customer liaison for quality for contract manufacturing customers.The Quality Assessor I is expected to perform the functions of the role with assistance from other assessors and their management.
Responsibilities:
- Manage deviations for assigned products.
- Manage out of specification and out of trend incidents for assigned products
- Manage NCMR for assigned products
- Manage CAPA for assigned products
- Provide routine instruction for quality incidents for assigned products
- Participate in triage for assigned product incidents.
- Review and approve finished product change controls.
- Review and approve manufacturing batch records.
- Review and approve packaging batch records.
- Review and approve laboratory specifications.
- Maintain relationship with contract customers.
- Meet with contract customers on a continuing basis.
- Notify contract customers of quality events
- Maintain personal training
- Attend meetings as assigned by management
Education/Qualifications:
- Bachelors Degree Required
- 4+ years of experience in the pharmaceutical industry and knowledge of cGMP is necessary. In lieu of degree, 6+ years of relevant experience will be considered.
- Understanding the functionality of the areas of production, packaging, or validation or an equivalent education in a science related discipline is required.
- The Assessor I is the entry level Quality Operations Assessor level.
- Demonstrated ability to prioritize, organize and work effectively.
- Strong observational skills and attention to detail are required.
- Strong communication skills (both oral and written) for internal contacts are required.
- Strong follow-up skills and the ability to provide timely closure of assigned tasks.
- Strong technical writing and problem solving skills. Experience in reviewing scientific documents/reports to assure compliance.
- Strong computer skills are required. Proficiency in the following are desired: Microsoft Word, Microsoft Excel and Microsoft Access.
- Strong interpersonal skills with the ability to achieve consensus and cooperation with varying departments and personalities.
- Personnel are expected to walk throughout the facility as necessary up to 10% of the time.
- Personnel may be required to lift up to 50 pounds.
