Career CategoryQuality
Job DescriptionSR ASSOCIATE QUALITY ASSURANCE - PQA - NIGHT SHIFTWhat you will doLet's do this. Let's change the world. In this vital role you will be the 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.*Candidate will be working on site. After the facility startup phase, the successful incumbent will be expected to transition to a shift working schedule, to include late afternoon and nights.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.
- 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 professional we seek is a person with these qualifications.
Basic Qualifications:- High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR
- Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience work experience OR
- Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience work experience OR
- Master's
Preferred Qualifications:- Strong cGMP and GDP behaviors
- Experience in biotechnology or pharmaceutical plant start up
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- Demonstrated experience with deviations records
- Experience 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 timelines
- Strong communication skills, both written and oral
- Demonstrated ability to work as a team player and independently
What 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 accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range82,081.95USD -111,052.05 USD
