Associate QC Biochemist

Role Summary

The Associate QC Biochemist performs compendial method testing, sample management, and stability management for biopharmaceutical products. Additional responsibilities include equipment management and laboratory duties. Location: Rockville, MD, USA.

Responsibilities

• Performs routine compendial testing (visual inspection, pH, osmolality, residual moisture, subvisible particulate matter) per SOP and GMP and utilizes electronic management systems in daily operations.
• Performs sample aliquoting on stability samples, coordinates sample shipments (reference standard, critical reagents, etc), and performs annual inventory inspections (reference standard, stability, retains) with proper GMP documentation. Option to learn to support small batch aseptic product stability fills as a runner and/ or assists with aseptic product reference standard fills.
• Performs laboratory duties and safety checks following all safety, GMP, CFR and other regulations in order to assure laboratory compliance.
• Assists in laboratory investigations and assay troubleshooting with supervisor/ manager.
• Evaluates laboratory SOPs and recommends improvement opportunities to maintain compliance with corporate and regulatory guidelines. Revises laboratory SOPs and WIs as assigned.
• Performs data verification for use in stability reports, and responsible for updating stability data tables and trends, as assigned.
• Operates and maintains QC laboratory equipment/ instrument per GMP, including responsibilities for installing / deactivating equipment/ instrument per GMP procedures, as assigned.
• Participates in the on-call response team for chamber excursions.
• Trained as a Self-Inspector Auditor and participates in department Self Inspections, as assigned.
• Able to work effectively as part of a team and exhibit effective interpersonal skills.

Qualifications

• Required: B.S. / B.A. degree in Chemistry, Biochemistry, or Biology.
• Required: This role is on-site at our United States facility. require occasional work outside standard hours for on-call duties.
• Preferred: Ability to work both individually and as part of a team with very good communication skills (verbal and written).
• Preferred: Strong organizational skills and effectively meets timelines.
• Preferred: Experience in cGMP-regulated environment.
• Preferred: Experience working with standard operating procedures.