Sr Associate QA - PQA - 1st Shift

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen is seeking a Sr Associate Quality Assurance (PQA) for 1st shift to partner with Manufacturing and Quality to sustain cGMP compliance across bulk drug substance operations and new product introductions. The role emphasizes real-time decision-making, coaching across events, deviations, CAPA, and validation activities on 24/7 operations.

You will support commissioning/qualification activities and provide on-the-floor QA oversight, ensuring products are manufactured, tested, stored, and

Qualifications

• High school/GED with 4 years in quality, manufacturing or regulated environments.
• Associates degree with 2 years in quality, manufacturing or regulated environments.
• Bachelors degree with 6 months in quality, manufacturing or regulated environments.
• Master's degree preferred.

Responsibilities

• Provide real-time quality oversight to ensure adherence to cGMP and GDP requirements.
• Coach and guide manufacturing events, deviations, CAPA, change control and validations.
• Support commissioning, qualification and validation activities for ANC facility and equipment.
• Lead audits and inspections support; interact with regulatory agencies as needed.
• Communicate quality issues to senior management and drive timely resolutions.

Skills

cGMP + GDP practices

Biotech/pharma plant startup

cGMP manufacturing knowledge

Upstream/downstream biotech制造

Education

High school/GED + 4 years of Quality/mfg work

Associates + 2 years of Quality/mfg work

Bachelors + 6 months of Quality/mfg work

Master's degree

Tools

MS Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Join Amgens Mission of Serving Patients

SR ASSOCIATE QUALITY ASSURANCE PQA - 1ST SHIFT

What you will do

Lets do this. Lets 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
• Associates + 2 years of Quality, manufacturing and/or other regulated environment work experience OR
• Bachelors + 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, well support your journey every step of the way.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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.