Sr Associate QA - Nights
Amgen
Summary
In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.
Job description
Responsibilities Include:
- Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
- Provide Quality oversight during on-the-floor analytical testing.
- Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
- Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs, and projects.
- Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off and receiving an added 15% shift differential.
Basic Qualifications:
- High school/GED + 4 years Quality Assurance or manufacturing work experience OR
- Associate’s + 2 years Quality Assurance or manufacturing work experience OR
- Bachelor’s + 6 months Quality Assurance or manufacturing work experience
- Master's
Preferred Qualifications:
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
Requirements
- High school/GED + 4 years Quality Assurance or manufacturing work experience OR
- Associate’s + 2 years Quality Assurance or manufacturing work experience OR
- Bachelor’s + 6 months Quality Assurance or manufacturing work experience
- Master's
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-based Long-term Incentives
- Paid Time Off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.