Senior Quality Control Associate

Fully Onsite | Holly Springs, NC

Shift: 10 hours per day, Wednesday–Saturday, **Night Shift | Shift starts at 10 PM

For training, they will begin on the day shift and then transition to the night shift.

-Experience in GMP or ISO-regulated environments/laboratory.

-Basic understanding of quality control testing workflows.

-Hands-on experience with LIMS.

-Primary focus is enhancing systems by which assures the safety of our biologic products.

Key responsibilities include: Ensure compliance with procedures relating to area of responsibilities. Proactive improvement of corporate quality management systems related to microbiology, viral clearance and container closure integrity mechanisms. Resolve bottlenecks related to key changes. Authorship of Operating Standard and SOP revisions. Own GMP materials relating to area of responsibility. Participate in regulatory inspections and site audits as needed.

Required/Basic Qualifications: BS in Chemistry, Microbiology or Science field. Experience working in a GMP environment/laboratory.

Preferred: Biotech or pharmaceutical industry experience. Knowledge of relevant analytical technologies associated with container closure integrity and viral clearance in a pharmaceutical setting. Able to successfully manage workload to timelines. Familiarity with basic project management tools. Strong experience in a laboratory environment. Scientific writing skills. Familiarity with (or ability to learn) SAP, EDMQ and laboratory documentation systems.