Amgen Job Openings – Specialist Plant Quality Assurance

Job Description:

• The Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and engineering staff to manufacture oncolytic virus based end-to-end drug substance and drug products for the global market. The PQA position will facilitate real-time decision making to ensure adherence to Good Manufacturing Practices (GMP) quality requirements. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing, Facilities & Engineering and Quality staff providing coaching, guidance and direction in regard to deviations, quality systems and compliance.

Job Responsibilities:

• Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
• 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 facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations
• Author/review/approve quality documents, such as: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports
• Audit and inspection support
• Assess changes that could potentially impact product quality
• Oversee and provide guidance during on-the-floor analytical testing
• Quality oversight of AWM site activities for facilities, utilities, equipment, systems and process with alignment and integration into the Amgen Quality Systems, including:
• Perform training activities
• Oversee execution of and change management related to the following: factory acceptance, commissioning tests, facility qualifications and validation activities
• 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
• Establish and enable LEAN practices
• Provide management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks

Qualification & Experience:

• Doctorate degree
• Master’s degree and 3 years of Quality or Manufacturing experience
• Bachelor’s degree and 5 years of Quality or Manufacturing experience
• Associate’s degree and 10 years of Quality or Manufacturing experience
• High school diploma / GED and 12 years of Quality or Manufacturing experience
• Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
• Previous Quality Assurance 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

Job Details:

Company: Amgen

Vacancy Type:  Full Time

Job Location: Manchester, NH, US

Application Deadline: N/A

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