Specialist Quality Assurance

About the role

Join Amgen’s mission of serving patients. In this vital role, you will provide quality assurance support to the Product Quality (PQ) organization as a subject matter expert of quality systems and records. You will collaborate within PQ and with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality, and Process Development on projects, issue resolution, and investigations.

The QA Specialist will use technical abilities and knowledge of QMS processes, procedures, and regulations to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation, including:

• Product specifications
• In-process control specifications
• Specification technical reports
• Annual product reviews (APRs)
• International expansion forms
• Change control records
• Appendix documents (data sheets and data analysis)
• Deviation Investigations/Root Cause Analysis
• CAPAs
• Analytical comparability protocols and reports
• Procedures

Additionally, this role will approve commercial variation records (GDCR) and may provide training to other staff.

Responsibilities

• Execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and provide business process support for APRs and site audits as needed.
• Support managing products in the annual product review cycles at Amgen.
• Provide QA Systems expertise and support to the Product Quality organization (PQ and Stability) within a team environment.
• Provide Product Quality QA support for one or more of Amgen's clinical and commercial products by working directly with Product Quality Leaders and Principal Product Quality Leaders on QA tasks.
• Perform QA tasks in support of both clinical and commercial Product Quality Leaders, including ownership, QA review, and approval of documents (Protocols, Reports, Specifications, IPCs, Annual Product Review, etc.) and execution of transactions in relevant GMP systems (VEEVA CDOCS, Change Control, Deviation/CAPA, etc.).
• Support audits/inspections, APR management, and other processes as required.
• Facilitate continuous improvement initiatives to increase Quality systems efficiencies within and outside the PQ organization.
• Interact with other functional areas within Amgen such as Corporate Quality, International Quality, Quality Control, Regulatory, Process Development, Site Quality Assurance, Supply Chain, and Manufacturing.

Requirements

Basic Qualifications

• Doctorate degree
• OR Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience
• OR High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products.
• General understanding of biopharmaceutical bulk and drug product development and manufacturing, and general knowledge of cGMPs.
• Previous experience using VEEVA, Trackwise, and other Amgen quality systems.
• Quality Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Specifications, SOPs, etc.).
• Strong investigation skills (related to Deviations/CAPAs/EVs) and/or experience owning change control records.
• Experience with Amgen variation management processes and systems.
• Experience working on a cross-functional team in a matrix environment and strong project management skills.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Competency in interacting with Senior Management.
• Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables.

Benefits

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.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on the careers site. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.