Sr Associate Quality Control I

Amgen Inc.; Holly Springs (NC); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to support initial lab start-up, qualification, and routine testing in the QC Chemistry lab. You will write procedures and reports, manage system transfers, and help implement computerized systems, with potential weekend work.

The role reports to the Director of Quality Control and requires collaboration across site teams to ensure successful training, validation, and change control processes in a GMP environment.

Qualifikationen

• Bachelor's degree in a related scientific field.
• 4+ years of GMP laboratory experience preferred.
• Experience with QC Chemistry/start-up activities.
• Strong written and verbal communication skills.

Aufgaben

• Lead QC Chemistry start-up activities including system qualification and validation and method transfers.
• Collaborate with site teams to establish work order and PM system for laboratory equipment.
• Review validation documents to support equipment and computerized system onboarding.
• Create and contribute to Data Integrity Assessments for computerized lab systems.
• Author, revise and review SOPs, test methods, safety assessments, trend reports, qualification/validation reports.

Kenntnisse

Quality control

Analytical testing

Technical writing

Team collaboration

Ausbildung

Bachelor's degree in Chemistry or related field

Tools

LIMS

LMES/CIMS

Jobbeschreibung

SR ASSOCIATE QUALITY CONTROL I

In this vital role you will be responsible for supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Responsibilities

• Leading the QC Chemistry start up activities including system qualification and validation and method transfers.
• Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
• Assisting with review of validation documents to support equipment and computerized system onboarding.
• Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Ensure successful training and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
• Own and manage Deviation, CAPA and Change Control records to support Quality Control.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required.

What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The vestal professional we seek is an effective leader with these qualifications.

Basic Qualifications

• High school/GED + 4 years of Quality work experience OR Associate’s + 2 years of Quality work experience OR Bachelor’s + 6 months of Quality work experience OR Master’s

Preferred Qualifications

• Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Strong knowledge of laboratory techniques.
• Proficient in the use of LIMS & LMES/CIMS.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

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.

Application deadlineAmgen 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 for this role is not guaranteed.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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.