QC Scientist II (2nd Shift)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 Bachelors 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.
• 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
• 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
• 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

Physical Requirements:

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.

What We Offer

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Compensation

• Competitive Pay
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits

• Benefits & Total Rewards Thermo Fisher Scientific
• Medical Dental & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities