Supervisor, QA - Batch Release jobs in United States
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Thermo Fisher Scientific · 2 weeks ago

Supervisor, QA - Batch Release

Thermo Fisher Scientific is an innovative organization seeking a Quality Assurance (QA) Supervisor for Batch Release. This role oversees QA activities, ensuring compliance with regulatory requirements and maintaining high standards of quality while providing leadership to assigned staff.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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Responsibilities

Champion Quality Culture: Aid personnel in understanding the application of policies and controls to promote a quality-focused culture
Leadership and Empowerment: Lead organizational change, empower staff, and cultivate relationships to build effective teams
Engagement and Motivation: Drive engagement and create a motivating climate to support staff in achieving personal career goals while meeting organizational goals
Supervision: Supervise staff performing quality and manufacturing audits, record review, final product release functions, complaints, APR, validation, and investigations
Quality Assurance: Ensure the quality of methods, processes, materials, and products through coordination and review of operations, staff training, and system/process improvements
Technical Expertise: Provide technical expertise for systems and new product introduction
Regulatory Compliance: Assure compliance with all applicable regulations by interpreting regulatory requirements and maintaining systems
Resource Management: Lead resources by budgeting and ensuring staff availability to meet business needs. Participate in budget planning and cost-saving projects
Performance Management: Ensure staff have performance plans with metrics in place, conduct performance reviews twice a year, and identify and handle performance/field issues
Training and Development: Provide training and career development opportunities for staff
Risk Assessment: Conduct risk assessments and take appropriate actions to ensure adequate controls for product quality, safety, and business risks

Qualification

CGMP knowledgeSupervisory experienceRegulatory complianceSAP familiarityLIMS familiarityOrganizational skillsEffective communicationTime managementInterpersonal skills

Required

Bachelor's degree required, preferably in a scientific related field
5+ years of experience in a cGMP manufacturing or QA Operations environment with strong knowledge of GMP operations and regulations
2+ years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry
2+ years supervisory/leadership experience required
Equivalent combinations of education, training, and relevant work experience may be considered
Proficient in cGMPs applicability and decision making
Ability to manage and lead professional staff to achieve goals and resolve complex technical problems
Strong organizational skills and attention to detail
Self-starter, mature, independent, and dependable
Ability to work in a fast-paced environment under pressure and multi-task
High degree of confidentiality and discretion
Effective time management and prioritization skills
Excellent interpersonal skills to establish and maintain effective working relationships
Highly effective verbal and written communication skills

Preferred

Familiarity with SAP, TrackWise, Electronic Document Management System (eDMS), and Laboratory Information Management Systems (LIMS) is an advantage
Familiarity with concepts, practices, and procedures related to Batch Release activities

Benefits

Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
401K
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities

Company

Thermo Fisher Scientific

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Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Funding

Current Stage
Public Company
Total Funding
$15.97B
Key Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B

Leadership Team

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Stephen Williamson
Senior Vice President and Chief Financial Officer
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Daniella Cramp
Senior Vice President and President, Bioproduction Group
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Company data provided by crunchbase