QC Scientist II (2nd Shift)

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
 

Join our Pharma Services Group (PSG) and be part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing. Biotech and biopharma companies trust us for our speed, flexibility, and quality across every phase of drug development. With global operations, we support active pharmaceutical ingredients (APIs), biologics, cell and gene therapy, viral vectors, formulation, clinical trials, logistics, commercial manufacturing, and packaging, delivering integrated solutions that help bring life-changing medicines to patients faster.

Within PSG, our Drug Product Division (DPD) supports customers in the formulation, production, and packaging of high-quality drug products. Our dedicated colleagues provide services including formulation development, process optimization, scale-up, sterile fill-finish, packaging, and labeling, ensuring efficient and compliant production of sterile injectable and oral dosage form products.

This role is based in Greenville, a site specializing in sterile injectable drug products from development through commercialization. Our Greenville colleagues prioritize product stability, patient safety, and long-term career growth, working with advanced technologies in a collaborative and supportive environment. Your career journey starts here.

Hours: M-F 3PM - 11PM

POSITION SUMMARY

Provides moderately complex analyses in a chemistry environment within defined procedures and practices. Performs analytical methods for moderately complex testing on in-process samples, finished product samples, stability samples and cleaning samples .  Supports internal manufacturing operations. Makes detailed observations, reviews documents, and communicates test results; recommends solutions.

Location

Key Responsibilities:

• Conducts moderately complex chemical and physical testing of in-process samples, finished product samples, stability samples and cleaning samples by internally developed and compendial test methods.
• Executes validated test methods for pharmaceutical in-process samples, finished product samples, stability samples and cleaning samples for strength, impurities and identity by  HPLC, GC and spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, spectroscopy, and/or traditional wet chemical testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; execute investigations in Trackwise from beginning to end and recommends solutions and path forward.  Experience with interaction with clients, communicates OOS results and investigations.  Work with Quality assurance to drive RCA for completion of Investigations and required corrective actions.
• Maintains and troubleshoots analytical instrumentation as needed.
• Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
• Writes SOPs and other instructional documents like Testing Procedures, Addendums and Specifications
• Performs all duties in strict compliance with Safety guidelines and procedures, Standard Operating Procedures, Good Manufacturing Practices and Good Laboratory Practices. Maintains the necessary compliance status required by company.

Qualifications:

• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing. Equivalent combinations of education and experience considered.
• 1+ years of