Sr Associate QA I – PQA

Amgen; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Amgen seeks a Sr Associate QA I — PQA to work with plant manufacturing and quality teams on bulk drug substance manufacturing and new product introductions. This role supports development, clinical, and commercial operations in a fast-paced, regulated environment.

The candidate will facilitate real-time decision making, ensure adherence to GMP quality requirements, and coach staff while driving deviations, CAPA, change controls, and validations.

Qualifications

• 4+ years in Quality, manufacturing or regulated environments.
• Biotech/pharma plant start-up experience preferred.
• Knowledge of cGMP and GDP practices.
• Experience handling deviations, CAPAs, change controls.

Responsibilities

• Staff for the PQA team and support 24/7 operations; potential shift work.
• Support commissioning/qualification and analytical equipment qualification.
• Provide quality oversight of new product introductions.
• Ensure products meet cGMP and GDP requirements.
• Lead timely completion of CAPAs, deviations, and validations.

Skills

Quality oversight

Regulated environment

cGMP knowledge

Document control

Quality systems

Education

High school/GED

Associate’s degree

Bachelor’s degree

Master’s degree

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

SR ASSOCIATE QA I — PQA

What You Will Do

Let’s do this. Let’s change the world. In this vital role you 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.
• Support ANC facility commissioning and qualification and manufacturing Analytical Equipment Qualification and Validation activities, perform quality review and approval of documents according to project timelines.
• 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 You

We 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 of Quality, manufacturing and/or other regulated environment work experience OR
• Associate’s + 2 years of Quality, manufacturing and/or other regulated environment work experience OR
• Bachelor’s + 6 months of Quality, manufacturing and/or other regulated environment 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 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, 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.

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.