FSP-REMOTE QC Reviewer/ Senior QC Reviewer

Lensa; Bridgewater (MA); Remote; USD 75,000 - 95,000; Full time

Job summary

Lensa is seeking a Senior QC Reviewer for Thermo Fisher Scientific, responsible for evaluating laboratory data, ensuring compliance with quality standards, and training new staff. This mid-senior level full-time position offers an opportunity to enhance your career within a leading global contract research organization dedicated to advancing science.

Qualifications

• 2+ years of relevant experience preferred.
• Expert knowledge of SOPs, GLP, and GMP required.

Responsibilities

• Perform complex analytical data reviews ensuring compliance and accuracy.
• Coordinate quality systems and address quality matters within the team.
• Train new QC Reviewers on best practices.

Skills

Attention to detail

Strong verbal and written communication skills

Ability to work in a collaborative team environment

Education

Bachelor's degree or equivalent

Job description

FSP-REMOTE QC Reviewer/ Senior QC Reviewer

FSP-REMOTE QC Reviewer/ Senior QC Reviewer

Lensa is the leading career site for job seekers at every stage of their career. Our client, Thermo Fisher Scientific, is seeking professionals. Apply via Lensa today!

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Description

As a Senior QC Reviewer you will perform a variety of complex analytical review for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. You will help coordinate and maintain different quality systems and be expected to weigh in on quality matters within the team. This position is focused on Large Molecule: ELISA, HPLC, CE-SDS, cIEF, SPR, and qPCR.

Summarized Purpose

Ensures the quality of laboratory data, reports, and systems. Reviews analytical data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP). Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation. Provides expertise to the laboratory and quality groups in one or more specialized areas such as chromatography, microbiology, method validation or other applicable areas.

Essential Functions

• Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/or non-routine projects.
• Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
• Reviews sample results for completeness and accurate representation of the data and reports findings.
• Provides expert knowledge in one or more analytical techniques (ELISA, HPLC, CE-SDS, cIEF, SPR, and qPCR) to assist laboratory and quality groups make informed decisions.
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.
• Trains new QC Reviewers and laboratory staff.
• Assists the departmental manager or supervisor in the evaluation of the laboratory QC program. Helps maintain compliance and assists in continuous improvement of laboratory processes.
• Performs other duties as assigned.
  
  

Qualifications - External

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills And Abilities

• Expert knowledge of SOPs and Federal Regulations to include GLP and GMP
• Expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to train staff
• Ability to deal with multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment
  
  

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Administrative

• Industries

  IT Services and IT Consulting

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