Associate Quality Control with GMP, Chemistry/Biochemistry, and Empower

Associate Quality Control with GMP, Chemistry/Biochemistry, and Empower Experience (Onsite Job in Holly Springs, NC)

Location: Holly Springs, NC

Terms: Contract W2 Only

Duration : 12 Months Contract (Will Get Extended for Long)

Description:

Fully Onsite - 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.

Position Summary:

We are 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.

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.

Skill Sets:

Must have a chemistry background

GMP experience

Empower experience