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 Apply Here vacancyoptions.com
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