Job Description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

GROUP/DIVISION SUMMARY

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.

POSITION SUMMARY

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.

Qualifications:

• 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.
• 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.
• 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.

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

Job Tags

Remote job, Full time, Work experience placement, Work at office, Day shift,

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