We are seeking a highly motivated and experienced Senior 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.
location: Apex, North Carolina
job type: Contract
salary: $29.00 - 33.56 per hour
work hours: 9 to 5
education: Bachelors
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 HPLC, UPLC, TOC, 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.
qualifications:
- Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Physics, 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 and equipment validation, including verification, transfer, and change control.
- Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.
skills: Quality control, HPLC, SOP, Analytical Chemistry, Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.