Supervisor, QA - Batch Release

Thermo Fisher Scientific•Greenville, NC

24d•Onsite

About The Position

The Quality Assurance (QA) Supervisor, Batch Release oversees QA activities and programs such as auditing, record review, final product functions, document management, complaints, oversight of quality systems, and investigations within QA. This role provides leadership to assigned staff, ensuring compliance with regulatory requirements and maintaining high standards of quality. Key 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.

Requirements

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.
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.
Must be legally authorized to work in the United States if now or in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening

Nice To Haves

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.

Responsibilities

Oversee QA activities and programs
Provide leadership to assigned staff
Ensure compliance with regulatory requirements
Maintain high standards of quality
Champion Quality Culture
Lead organizational change
Empower staff
Cultivate relationships to build effective teams
Drive engagement and create a motivating climate
Supervise staff performing quality and manufacturing audits, record review, final product release functions, complaints, APR, validation, and investigations
Ensure the quality of methods, processes, materials, and products through coordination and review of operations, staff training, and system/process improvements
Provide technical expertise for systems and new product introduction
Assure compliance with all applicable regulations by interpreting regulatory requirements and maintaining systems
Lead resources by budgeting and ensuring staff availability to meet business needs
Participate in budget planning and cost-saving projects
Ensure staff have performance plans with metrics in place, conduct performance reviews twice a year, and identify and handle performance/field issues
Provide training and career development opportunities for staff
Conduct risk assessments and take appropriate actions to ensure adequate controls for product quality, safety, and business risks

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