Career CategoryQuality
Job DescriptionSPECIALIST QA 1What you will doLet's do this. Let's change the world. In this vital role you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsibilities include the following:
- Responsible for providing Quality oversight to ensure that Operations' products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution 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.
- Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
- Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
- Oversee and provide guidance during on-the-floor analytical testing.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- 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 Quality Assurance professional we seek is a Specialist with these qualifications.
Basic Qualifications:- High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Associate's degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Bachelor's degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Master's degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Doctorate degree
Preferred Qualifications:- Educational background in Life Science or Engineering.
- Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
- Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition
- Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
- Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
- Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
- Strong organizational skills, including ability to follow assignments through to completion.
- Excellent written and verbal communication skills.
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 $xxx,xxx.00 to $xxx,xxx.00. 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.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
