Associate Quality Control

Job Title: Associate Quality Control
Location: Holly Springs, NC 27540
Duration: 12 Months (Possibility of extension depending upon business requirements and performance)
Shift: Standard hours - Up to 5 days per month may require shift flexibility.

Ideal Candidate: B.S. and 3+YOE would be ideal in a chemistry lab environment.

Top 3 Must Have Skill Sets:

• Must have a chemistry background
• GMP experience
• Empower experience

Position Summary:

• The client is seeking a highly motivated and experienced Associate in Quality Control (QC) Chemistry to support the startup and operational readiness of our QC laboratory.
• Working with minimal supervision, this individual will lead and contribute to critical activities including system qualifications, method transfers, and laboratory operations in a GMP-regulated environment.

Key Responsibilities:

• Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.
• Review and contribute to validation documentation to support onboarding of equipment and computerized systems.
• Draft, revise, and review technical and quality documentation such as SOPs, test methods, technical assessments, validation reports, trend reports, and safety evaluations.
• Assist in the procurement of laboratory consumables and critical reagents required for startup activities.
• Coordinate and execute training and method transfer activities for instruments including H/UPLC, TOC, Conductivity, Osmolality and other chemistry-based platforms.
• Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.
• Provide routine operational support during weekends and public holidays as required.

Day to Day Responsibilities:

• Laboratory testing of manufactured materials.
• Training on new methods
• Audit readiness
• Support startup

Preferred Qualifications:

• Bachelor's degree or higher in Chemistry, Compendial testing or a related scientific discipline.
• Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing.
• Proficient in analytical laboratory techniques and instrumentation.
• Familiarity with laboratory systems such as LIMS and LMES/CIMS.
• Demonstrated understanding of industry regulations, data integrity, and compliance standards.
• Strong technical writing, documentation, and communication skills.
• Experience with method validation, verification, and transfer.
• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.

Basic Qualifications:

• High school/GED + 2 years work experience

OR

• Associates degree and 6 months work experience

OR

• Bachelors degree

Possible Extension: Yes

Red Flags:

• No chemistry background
• Not able to be flexible.
• Not able to work overtime when needed.

Interview Process:

• Interview will be with the hiring manager and the Sr Manager