FSP-REMOTE QC Reviewer/ Senior QC Reviewer

Thermo Fisher Scientific; New Jersey; Remote; USD 35,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector seeks a Senior QC Reviewer for complex analytical review of pharmaceutical and biopharmaceutical products. The role requires expertise in chromatography and ensures compliance with quality standards. Candidates with a Bachelor's degree and relevant experience are encouraged to apply.

Qualifications

• Bachelor's degree or equivalent and relevant experience.
• Previous experience equivalent to 2+ years.
• Knowledge of GLP and GMP.

Responsibilities

• Perform complex analytical data review for pharmaceuticals.
• Ensure compliance with analytical methods and scientific soundness.
• Train new QC Reviewers and laboratory staff.

Skills

Expert knowledge of SOPs

Strong attention to detail

Strong verbal and written communication skills

Ability to train staff

Education

Bachelor's degree or equivalent

Tools

Chromatography techniques

Job description

FSP-REMOTE QC Reviewer/ Senior QC Reviewer

Join to apply for the FSP-REMOTE QC Reviewer/ Senior QC Reviewer role at Thermo Fisher Scientific

FSP-REMOTE QC Reviewer/ Senior QC Reviewer

Join to apply for the FSP-REMOTE QC Reviewer/ Senior QC Reviewer role at Thermo Fisher Scientific

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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
  
  

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Product Management, and Engineering

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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