JOB DESCRIPTION
Work Schedule
12 hr shift/nightsEnvironmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), WarehouseJob 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.
As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
This position has 3 openings. One is day shift/12-hour Say Shift (6am-6pm), and two are night shift/12-hour Night shift from 6pm-6am on a 3-2-2 rotation. Flexibility to work overtime as needed.
Join our Quality Assurance team at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. As a QA Supervisor, you'll lead and develop a team of quality professionals while overseeing quality operations including batch record review, quality monitoring, and continuous improvement initiatives.
You'll collaborate with cross-functional teams to enhance quality excellence and maintain our high standards for product safety and compliance.
This position offers the opportunity to contribute by helping ensure the quality of products that enable our customers to make the world healthier, cleaner and safer.
BS degree required.
Preferred Fields of Study: Biology, Chemistry, Engineering
Advanced degree preferred.
Professional certifications (e.g., CQE, ASQ) desirable.
Advanced Degree plus 2 years of experience, or bachelor's degree plus 3-5 years of experience in quality assurance in a regulated manufacturing environment required (pharmaceutical, medical device, or related industry preferred).
2 -5 years of supervisory/leadership experience required.
Experience with batch record review, deviation management, and CAPA systems
Experience developing and delivering quality-related training.
Experience hosting regulatory inspections and customer audits.
Comprehensive knowledge of cGMP regulations, ISO standards, and quality systems
Strong understanding of quality risk management principles and tools
Demonstrated success in implementing quality improvements and leading change initiatives
Expertise in quality documentation systems and electronic quality management tools
Excellent project management and organizational skills
Strong analytical and problem-solving abilities
Excellent written and verbal communication skills
Ability to build relationships and collaborate across all organizational levels
Proficiency with quality management software systems (e.g., TrackWise, SAP)
Comprehensive understanding of validation principles and requirements
Demonstrated ability to support quality culture and continuous improvement
Strong decision-making skills with focus on risk-based approaches
Ability to effectively manage multiple responsibilities in a deadline-oriented environment
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, 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.
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