Quality Control Senior Associate

Collabera; Holly Springs (NC); On-site; USD 55,104 - 59,236; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long‑term disability insurance

Short‑term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Paid vacation time

Paid parental leave

Paid holidays annually

Job summary

Collabera is seeking a Quality Control Senior Associate in Holly Springs, NC for a 12-month position. The role involves ensuring compliance with quality procedures and improving corporate quality management systems. The ideal candidate will possess a BS in Chemistry or related fields and have experience in GMP laboratory settings.

This position also offers a range of benefits including medical, dental, and vision insurance, as well as additional perks such as a 401(k) plan and paid time off.

Qualifications

• Experience in GMP or ISO-regulated environments/laboratory.
• Basic understanding of quality control testing workflows.
• Experience working in a GMP environment/laboratory.

Responsibilities

• Ensure compliance with procedures relating to area of responsibilities.
• Proactive improvement of corporate quality management systems.
• Resolve bottlenecks related to key changes.

Skills

GMP environment experience

Laboratory experience

Scientific writing skills

Project management familiarity

LIMS hands-on experience

Education

BS in Chemistry, Microbiology or Science field

Tools

SAP

EDMQ

Job description

Title: Quality Control Senior Associate

Duration: 12 Months

Location: 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.

Key Responsibilities

• 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.

Must Haves

• Experience in GMP or ISO-regulated environments/laboratory. Basic understanding of quality control testing workflows.
• Hands‑on experience with LIMS.

Salary and Other Compensation

The annual salary for this position is between $40.00 - 43.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long‑term disability insurance
• Short‑term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time
• Paid vacation time
• Paid parental leave
• Paid holidays annually
• Any additional benefits applicable