QA Supervisor (1 Day Shift & 2 Night Shift Positions)

Thermo Fisher Scientific•Greenville, NC

1d•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, contributing to the mission of enabling customers to make the world healthier, cleaner, and safer. The company provides resources for individual career goals and develops solutions for global challenges like environmental protection, food safety, and cancer research. This position is within the Drug Product Division (DPD) at the Greenville, North Carolina site, which is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The DPD-NA comprises approximately 4400 colleagues across six sites, specializing in sterile injectable and oral solid dose drug products from development to commercialization. There are three openings for this role: one day shift (6am-6pm) and two night shifts (6pm-6am) on a 3-2-2 rotation, with flexibility for overtime. As a QA Supervisor, you will join the Quality Assurance team to ensure product quality and regulatory compliance. Your role involves leading and developing a team of quality professionals, overseeing quality operations such as batch record review, quality monitoring, and continuous improvement initiatives. You will also collaborate with cross-functional teams to enhance quality excellence and maintain high standards for product safety and compliance, ultimately contributing to the quality of products that improve global health and safety.

Requirements

BS degree required
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
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

Nice To Haves

Advanced degree preferred
Professional certifications (e.g., CQE, ASQ) desirable
Experience in pharmaceutical, medical device, or related industry preferred

Responsibilities

Lead and develop a team of quality professionals
Oversee quality operations including batch record review, quality monitoring, and continuous improvement initiatives
Collaborate with cross-functional teams to enhance quality excellence
Maintain high standards for product safety and compliance