QA officer at Thermo Fisher Scientific

Swindon, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Life SciencesIndustries

Requirements

Preferred relevant science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy
Proven experience in the pharmaceutical industry, preferably in sterile product manufacture
In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing
Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization
Proactive approach to continuous improvement and project work

Responsibilities

Offer quality assurance supervision for operational tasks within the designated team
Review sterilization cycles, FMS systems, and other key controls of clean rooms
Manage logbooks and support area controls
Perform online review of batch records
Close batch records with associates LIMS & SAP transactions and C of A generation
Review and update Standard Operating Procedures and Controlled Documents
Direct clean rooms and support zones; ensure behavior and conformity to SOPs, including entering clean rooms physically and keeping up with at least an L1 license
Direct the packaging departments; uphold conduct standards and adherence to SOPs
Actively produce and promptly assess minor DRs & CAPA with cell members
Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members
Conduct local area and local system audits
Train and mentor Operations staff and QA peers
Communicate effectively, attend Tier 1 meetings, and participate in planning and problem-solving activities
Offer re-validation resources to the aligned cell effectively
Observe, incubate, read, and write reports for media fills
Conduct clean room physical checks – velocities, air patterns, DOP tests, and particle counting
Perform autoclave load pattern re-qualification
Test sterilizing filters
Validate cleaning processes
Conduct AQL-based Visual Inspection

Skills

Key technologies and capabilities for this role

LIMSSAPSOPsCAPACleanroom ManagementSterilization CyclesBatch RecordsAuditsMedia FillsParticle CountingAutoclave QualificationFilter TestingAQL Inspection

Questions & Answers

Common questions about this position

What is the compensation for this QA Officer role?

The package includes competitive pay along with a variety of adaptable benefits like Pension and Healthcare.

Is this QA Officer position remote or on-site?

This is an on-site role in Swindon, UK, involving 12-hour night shifts in cleanroom and office environments with physical presence required for tasks like directing clean rooms and conducting checks.

What skills and qualifications are required for the QA Officer position?

Preferred qualifications include a relevant science-based degree such as Microbiology, Chemistry, Biology, or Pharmacy, proven experience in pharmaceutical industry sterile product manufacture, in-depth knowledge of cGMP and regulatory guidelines, and excellent interpersonal skills.

What is the company culture like for this role at Thermo Fisher Scientific?

The culture features an enthusiastic team focused on making a tangible difference, with emphasis on hands-on involvement, effective communication, Tier 1 meetings, training, mentoring, and continuous improvement.

What makes a strong candidate for this QA Officer role?

Strong candidates have a science-based degree, pharmaceutical experience in sterile manufacturing, deep cGMP knowledge, excellent interpersonal skills to challenge behaviors at all levels, and a proactive approach to continuous improvement.

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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