Quality Control Scientist- Raw Materials

Aerotek Scientific is actively recruiting for a Quality Control Scientist in the Raw Materials (RM) group of a growing CDMO that perform routine and more complicated tasks in support of raw material sampling, testing, and disposition for GMP manufacturing. This position will also participate in QC analytical method trouble-shooting, investigations of OOS/OOT results, and authoring of raw material methods and procedures. The ideal candidate has previous GMP experience in sampling and testing raw materials, commissioning of analytical instruments, technical writing, and experience working in a fast-paced, dynamic environment.

PRINCIPAL RESPONSIBILITIES:

• Support the sampling, testing, and disposition of raw materials in advance of Manufacturing needs: sample GMP materials per documented procedures, perform both routine and complex laboratory testing, review internal and vendor test documentation, and track testing progress against due dates and KPIs.


• Maintain the laboratory in a GMP inspection ready state: order standards and reagents as necessary, perform scheduled instrument maintenance, maintain current GMP and Environmental Health & Safety (EHS) training, inspect raw material retains, and periodically dispose of samples from dispositioned lots.


• Support the onboarding of new laboratory equipment and software systems, including user requirement specifications, validation protocols and reports, authoring of operation and maintenance procedures, and data integrity risk assessments.


• Ensure the GMP compliance within QC raw materials: perform GMP activities as per documented procedures, accurately document all sampling, testing, and instrument maintenance activities, lead laboratory investigations, change control activities and CAPAs, author and review test methods and quality system SOPs, and participate in continuous improvement projects.


• Coordinate the shipment and testing of raw material samples at contract laboratories, track testing due dates and turnaround times, review contract test lab data, and support laboratory investigations as needed.

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to understand analytical/technical data.


• Good organizational skills and attention to detail.


• Experience participating in laboratory investigations of deviations, OOS/OOT results, 5 whys, CAPA, and other quality system functions.


• Experience in preparing for or participating in laboratory compliance audits and/or inspections by regulatory agencies.


• Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.


• Experience working in cross-functional teams.


• High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.

EDUCATION/EXPERIENCE:

• Education: Minimum BS in Biology, Biochemistry or other scientific discipline.


• Experience: Minimum of 8+ years hands-on experience in a GMP laboratory or manufacturing environment.


• Experience managing suppliers and/or contract testing laboratories preferred.

Please apply with an updated resume and 3 professional references

About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.