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 D 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.

Job Description

•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

•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

•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

•Assess changes that could potentially impact product quality

•Provide 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, and ensure training of staff, to permit execution of required tasks.

•Perform training activities

•Drive operational improvement initiatives, programs and projects

Responsibilities:

•Support AR 30 startup activities for facilities, utilities, equipment and systems including:•Author/review quality documents, related to:  SOPs, user requirements, risk assessments, training materials, engineering, automation, commissioning, facility, utility, environmental qualification, validation.

•Support execution of, and change management related to, the following:  site acceptance, commissioning tests, facility qualifications and validation activities.

•Execute daily operations per management guidance in a dynamic environment.

•Perform OTF quality review of documents, such as:  equipment logs, training records, testing results, batch records and supporting documents.

•Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.

•Provide guidance during on-the-floor analytical testing.

•Support audits, inspections and investigations, as needed.

•Adhere to LEAN practices and contribute to culture of continuous improvement.

Basic Qualifications

Master’s degree
OR
Bachelor’s degree and 2 years of quality assurance experience
OR
Associate’s degree and 6 years of quality assurance experience
OR 
High school diploma / GED and 8 years of quality assurance experience

Preferred Qualifications

• Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
• Previous QA oversight of manufacturing, analytical and engineering activities
• Experience in investigations, change controls, and CAPAs processes system knowledge
• Experience and training in EDMQ, Trackwise, Maximo, LIMS
• Experience in managing multiple, competing priorities in a fast-paced environment
• Experience leading and/or managing teams
• Direct bulk drug substance and drug product experience
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
• Ability to solve complex problems and make scientific risk-based decisions
• Experience representing Amgen while interacting with representatives of regulatory agencies
• Experience of trending analysis
• Demonstrated proficiency using Excel, Word and Power Point
• Open to travel