Manager, Quality Control at Thermo Fisher Scientific

High Point, North Carolina, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Life Sciences, ManufacturingIndustries

Requirements

  • BS degree with 8 years of laboratory experience preferably within a cGMP, pharmaceutical laboratory environment, including 2-3 years of supervisory experience
  • Meet applicable DEA security clearance requirements
  • Skilled in the interpretation of guidelines and employing rational or scientific reasoning
  • Proficiency in operating basic and complex laboratory equipment and software such as Empower, Chromeleon, MS Word, and Excel

Responsibilities

  • Ensures that the QC laboratory is well-equipped with the necessary personnel to conduct timely testing of non-commercial and pre-commercial samples, encompassing both process and cleaning validations
  • Provide mentorship and technical support to staff in troubleshooting instrumentation, root cause analysis, and implementing Corrective/Preventative Actions (CAPAs)
  • Collaborate with internal and external customers to support site and company initiatives
  • Uphold and implement safety regulations and company policies
  • Conduct regular 1-on-1 mentoring sessions and annual performance evaluations for team members
  • Represent Quality Control during audits and regulatory inspections

Skills

Key technologies and capabilities for this role

GMPCAPARoot Cause AnalysisProcess ValidationCleaning ValidationInstrumentation TroubleshootingAuditsRegulatory InspectionsLaboratory Testing

Questions & Answers

Common questions about this position

What benefits are offered for this position?

The company provides an excellent benefits package including medical, dental, and vision benefits effective Day 1, paid time off and holidays, 401K company match up to 6%, tuition reimbursement after 90 days, employee referral bonus, employee discount program, recognition program, charitable gift matching, and company paid parental leave.

Is this a remote position or does it require on-site work?

This is an on-site position located in High Point, NC, in a laboratory setting with adherence to GMP safety standards.

What qualifications and skills are required for the Manager, Quality Control role?

A BS degree with 8 years of laboratory experience preferably in a cGMP pharmaceutical environment including 2-3 years supervisory experience is required, along with DEA security clearance, skills in interpreting guidelines using scientific reasoning, and proficiency in laboratory equipment and software like Empower, Chromeleon, MS Word, and Excel.

What is the work schedule for this role?

The work schedule is standard Monday through Friday.

What experience makes a strong candidate for this position?

Candidates with a BS degree, 8+ years in a cGMP pharmaceutical lab including 2-3 years supervising, DEA clearance eligibility, and hands-on proficiency with lab instruments and software like Empower stand out, especially those skilled in root cause analysis, CAPAs, and regulatory audits.

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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