Specialist Quality Assurance

BioSpace; Washington (District of Columbia); On-site; USD 100,000 - 140,000; Full time

Job summary

Amgen is seeking a Specialist Quality Assurance to provide QA systems expertise and lead quality assurance responsibilities within the Product Quality (PQ) organization. You will own and review Product Quality records, collaborate with Manufacturing, Regulatory, and Supply Chain teams, and support CAPAs, audits, and APR processes.

The role requires strong experience with GMP systems, such as VEEVA CDOCS and Trackwise, and the ability to manage multiple tasks in a matrix environment while

Qualifications

• Doctorate or master's with QA/Manufacturing experience
• Bachelor's with 4 years QA/Operations/Manufacturing experience
• High school diploma with 10 years QA/Manufacturing experience

Responsibilities

• Provide QA systems expertise to the Product Quality organization.
• Review and approve documents in GMP systems (VEEVA CDOCS, Change Control, Deviation/CAPA).
• Lead deviation investigations and CAPAs as assigned.
• Support audits/inspections and APR management.
• Collaborate with cross-functional teams across PQ, Regulatory, and Supply Chain.

Skills

QA systems

QA documentation

GMP systems

Cross-functional teamwork

Project management

Communication skills

Education

Doctorate degree

Masters degree with 2+ years

Bachelors degree with 4+ years

Associate degree with 8 years

High school diploma / GED with 10 years

Tools

VEEVA CDOCS

Trackwise

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Quality Assurance

What You Will Do

Lets do this. Lets change the world. In this vital role you will provide quality assurance support to the PQ organization as a subject matter expert of quality systems and records. In this team-based role you will directly add to the success of the Product Quality team by collaborating within PQ and with diverse levels in 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 docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures. Additionally, this role will approve commercial variation records (GDCR), and may provide training to other staff.

Responsibilities

As a team member you will use your technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits, as needed. The QA specialist may also support managing products in the annual product review cycles at Amgen.

• Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability) by working within a team environment.
• Provide Product Quality QA support to 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.
• Responsible for 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 (Owner and/or QA Contact) in relevant GMP systems (VEEVA CDOCS, Change Control, Deviation/CAPA, etc.) and may include additional business process support.
• Support of audits/inspections, APR management, and other processes as required.
• Supporting/facilitating continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of 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, Manufacturing, etc.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications

• Doctorate degree Or
• Masters degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience Or
• Bachelors degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience Or
• Associates 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.

What You Can Expect From Us

As 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, well 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.

In 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 deadline

Amgen 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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.