Sr Associate QA
One Amgen Center Drive Thousand Oaks, California 91320 | Contract
The DS/DP/CB Floor Quality Assurance team provides quality and compliance oversight of the manufacturing plants for the Cell Bank, Drug Substance, and Drug Product stages. This includes cell bank, cell culture, purification, and aseptic formulation/fill/finish processes. The position also provides quality oversight of plant support functions such as maintenance, metrology, engineering, and automation.
- Provide Quality Assurance oversight for manufacturing and support operations for biopharmaceutical products.
- Ensure compliance to GMP regulations for area operations and associated or support processes.
- Support investigations/deviation reports (nonconformance reports).
- Management of GMP documentation including real time manufacturing document review, approval, and archiving.
- QA contact and approver for Class 1 Nonconformances.
- Provide plant floor Quality oversight to maintain an inspection ready facility as part of 75% required time on the manufacturing floor.
- May be asked to give additional assistance to management within the Quality Assurance group as needed. For example, metrics compilation or data gathering, project support, etc.
- Bachelor’ s Degree in Biochemistry, Biology, Chemistry, or related science field.
- Demonstrated science based approach and an ability to deliver results.
- Experience working in multiple GMP databases.
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
- Experience in review and approval of batch records, NC/CAPA' s and Change Control records.
- Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation.
- Previous experience in quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo).
- Ability to focus on detail and ensure the accuracy of executed tasks and documentation per GMP standards.
- Effective verbal and technical written communication skills.
- Strong interpersonal skills to articulate quality requirements and rationale to others.
- Knowledgeable of regulatory requirements/Quality Principles.
- Able to effectively handle and operate in a rapidly changing environment.
- Strong team player.
- Complex decision-making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.
- Experience performing batch record review and previous manufacturing experience.
- 1+ years of experience.
Candidate must be able to work day shift or swing shift. Candidate must be flexible to allow for shift changes.
TOP 3 MUST HAVE SKILL SETS:
- Experience in manufacturing or quality fields within biotech or pharma industries.
- Complex decision making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.
- Technical writing skills The ideal candidate would have applicable drug substance/drug product bio-tech manufacturing facilities as a QA or from a manufacturing background.