Location: Holly Springs,NC, USA
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.
Quality Assurance Specialist
What you will do
Lets do this! Lets 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. Amgens 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 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 dynamic 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
Associates degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Bachelors degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Masters degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Doctorate degree
Preferred Qualifications:
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.
Proven 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 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, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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.
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.