Supervsior, QA - Batch Release at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

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
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: Ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically

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

Skills

GMP

Quality Assurance

Auditing

Batch Release

Record Review

Regulatory Compliance

Investigations

Validation

Document Management

Staff Supervision

Quality Systems

APR

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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