Associate QC I

Amgen • Holly Springs, NC

2d

About The Position

The Associate QC I supports the Chemistry laboratory startup at Amgen’s Holly Springs facility and performs qualification and routine testing. The role includes writing procedures and reports; supporting laboratory equipment installation, qualification, and validation; transferring methods; developing training; and supporting implementation of computerized systems. The position supports manufacturing operations, and extended hours, shift work, weekend work, and public-holiday work may be necessary.

Initially reporting to the Director of Quality Control, this role supports startup of the QC organization under minimal supervision and serves as a subject matter expert in QC Chemistry laboratory operations and testing. Responsibilities also include supporting GMP and stability testing, laboratory equipment maintenance systems, data integrity assessments, procurement of laboratory supplies, and audits and projects.

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.
• Ability to interact effectively with varied communication and working styles and to work well in teams.

Nice To Haves

• A degree in a related scientific field such as Chemistry, Biochemistry, Physics, or Chemical Engineering.
• 4 or more years of relevant laboratory experience in a GMP commercial manufacturing environment in the pharmaceutical or biopharmaceutical industry, with analytical testing experience.
• Experience with equipment and method validation, verification, and transfer, including the change control process.

Responsibilities

• Participate in QC Chemistry startup activities, including execution of system qualification and validation and method transfers.
• Work with site teams to establish work-order and preventive-maintenance systems for laboratory equipment.
• Assist with 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 transfer methods 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 initial laboratory equipment installation, qualification, and validation.
• Support method transfers, training development, and implementation of computerized systems.

Benefits

• Comprehensive employee benefits package, including a retirement and savings plan with company contributions, 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.

What This Job Offers

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