Career Category

Job Description

The AR30 Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, launch and commercial operations.  The PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements.  This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction in regard to deviations, quality systems and compliance. 

The Plant Quality Assurance team shift structure aligns with Manufacturing, which is a 12-hr rotating shift work schedule.   For this specific night shift role, the shift pattern will be a 7PM – 7AM structure with a rotation that offers an average of 14 days on shift per month with every other weekend off. There are 2 openings for this position.

Responsibilities:

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
• Oversee and provide guidance during on-the-floor analytical testing.
• Audit and inspection support.
• Assess changes that could potentially impact product quality.
• Support management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.
• Complete required assigned training for self to permit execution of required tasks.
• Perform training activities, as needed.
• Support operational improvement initiatives, programs and projects.

Basic Qualifications:

• Master's Degree
• OR
• Bachelor's Degree and 2 years of Quality experience
• OR
• Associate's degree and 6 years of Quality experience
• OR
• High school diploma/GED and 8 years of Quality experience

Preferred Qualifications:

• Strong cGMP and GDP behaviors
• Demonstrated experience with deviations and CAPA records
• Previous experience supporting GMP testing laboratories.
• Knowledge of electronic systems including LIMS, Trackwise, and Maximo
• Strong word processing, presentation, database and spreadsheet application skills
• Strong organizational skills and ability to manage multiple tasks at one time
• Ability to follow assignments through to completion and meet timelines
• Exposure to regulatory agency inspectors or participation in regulatory agency audits.
• Strong technical communication skills, both written and oral
• Demonstrated ability to work as a team player and independently

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.