Sr Associate QA - Plant Quality Assurance (PQA) - Night Shift

Amgen Sr Associate Qa Plant Quality Assurance (Pqa) - Night ShiftJoin Amgen's mission of serving patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Sr Associate Plant Quality Assurance (PQA)- Night shiftIn this vital role Amgen North Carolina (ANC) Sr. Associate 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, and commercial operations.The Sr Associate 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 for manufacturing events, deviations, quality systems and compliance.Staff for the PQA team are on-site workers. The Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. There are several openings for this position. The successful incumbent will be expected to transition to a shift working schedule, to include late afternoons and nights.Responsibilities include: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.Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.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.Oversee and provide guidance during on-the-floor analytical testing.Ensure that changes that could potentially impact product quality are assessed according to procedures.Ensure that deviations from established procedures are investigated and documented per procedures.Alert senior management of quality, compliance, supply and safety risks.Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.Identification and implementation of continuous improvement opportunities within our processes and systems.Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a team player with these qualifications.High school/GED + 4 years Quality, Manufacturing and/or other regulated environment experience ORAssociate's + 2 years Quality, Manufacturing and/or other regulated environment experience ORBachelor's + 6 months Quality, Manufacturing and/or other regulated environment experienceMaster'sStrong cGMP and GDP behaviorsExperience in biotechnology or pharmaceutical plant start upKnowledge and process experience within a cGMP manufacturing facility or other highly regulated environmentTechnical understanding of upstream and/or downstream manufacturing within a biotechnology production operationProficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality SystemsDemonstrated experience with deviations recordsExperience supporting GMP testing laboratories.Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelinesStrong communication skills, both written and oralDemonstrated ability to work as a team player and independentlySome of the vast rewards of working hereAs we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on GlassdoorWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleApply now and make a lasting impact with the Amgen team.