Associate QC I

Amgen • Holly Springs, NC

3d • $62,572 - $84,656

About The Position

The Associate QC I supports startup of the Chemistry laboratory at Amgen’s Holly Springs Facility, followed by qualification and routine testing in support of the facility. The role includes writing procedures and reports; supporting installation, qualification, and validation of laboratory equipment; conducting method transfers; developing training; and supporting implementation of computerized systems. The position supports manufacturing operations, so extended hours, shift work, and weekend work may be necessary. The posting states that the role initially reports directly to the Director of Quality Control and will serve as a subject matter expert on QC Chemistry laboratory operations and testing.

Under minimal supervision, the successful candidate helps launch the QC organization, supports GMP and stability testing, and works with site teams on laboratory systems, equipment, and operational needs. The role also participates in audits, initiatives, and projects that may involve other departments or have a global scope.

Requirements

• High school diploma or GED and 2 years of quality work experience, or an associate degree and 6 months of quality work experience, or a bachelor's degree.
• Strong knowledge of laboratory techniques.
• Proficiency in LIMS and LMES/CIMS.
• Knowledge of relevant regulatory and 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 change control.
• Ability to interact effectively with varied communication and working styles and work well in teams.

Nice To Haves

• A degree in a related scientific field such as Chemistry, Biochemistry, Physics, or Chemical Engineering.
• Four or more years of relevant laboratory experience in a GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry, with analytical testing experience.

Responsibilities

• Participate in QC Chemistry startup activities, including system qualification, validation, and method transfers.
• Collaborate with site teams to establish work-order and preventive-maintenance systems for laboratory equipment.
• Assist in creating and collaborating on data integrity assessments for computerized laboratory systems.
• Review and approve QC method executions for GMP and stability support.
• Assist with procurement of consumables and critical reagents for routine laboratory activities.
• Execute and support method-transfer activities for HPLC, UPLC, TOC, and other related chemistry benchtop equipment.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities on weekends and public holidays as required.
• Write procedures and reports and support laboratory equipment installation, qualification, and validation.
• Develop training and support implementation of computerized systems.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.
• Work/life balance support.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED