QC Scientist II (2nd Shift)

Thermo Fisher Scientific•Greenville, NC

13d•Onsite

About The Position

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

Requirements

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 chromatographic data acquisition systems and HPLC experience preferred.
Strong knowledge of cGMP regulations and quality control requirements
Experience with laboratory information management systems (LIMS) and quality management systems
Excellent documentation practices and attention to detail
Strong problem-solving and analytical skills
Ability to work both independently and collaboratively
Proficiency with Microsoft Office applications
Strong written and verbal communication skills
Ability to lift up to 30 pounds and stand for extended periods
Willingness to wear required PPE including lab coat, safety glasses, and gloves
May require flexible scheduling including occasional weekend work
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations.
Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time
Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds.
Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time.
Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time.
Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

Nice To Haves

Experience with method validation and transfer activities preferred
Knowledge of data integrity requirements and good documentation practices
Demonstrated ability to investigate out-of-specification results and author technical reports
Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field
Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods

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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Competitive Pay
Annual performance-based bonus
Annual merit performance-based increase
Excellent Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
401K
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities