Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Biopharmaceutical Production Manager Jobs
Recruited by GSK 8 months ago Address King of Prussia, PA, United States
Gmp Document Reviewer Jobs
Recruited by Quotient Sciences 10 months ago Address Boothwyn, PA, United States
Qc Biochemistry-Potency Supervisor Jobs
Recruited by GSK 11 months ago Address , King Of Prussia, 19406, Pa
Medical Assistant, Senior Jobs
Recruited by UPMC 11 months ago Address Mechanicsburg, PA, United States
Biopharmaceutical Production Manager Jobs
Recruited by GSK 11 months ago Address , King Of Prussia, 19406, Pa
Qc Compliance Specialist Jobs
Recruited by INCOG BioPharma Services 1 year ago Address Indiana, United States
Director Qa/Qc/Sop/Design
Recruited by Jefferson - Center City, Philadelphia, PA 1 year ago Address , Philadelphia, 19107, Pa
Qc Analyst Jobs
Recruited by Proclinical Staffing 1 year ago Address Philadelphia, PA, United States
Qc Analyst Jobs
Recruited by Sparx Therapeutics 1 year ago Address , Philadelphia, 19104, Pa

Senior Qc Reviewer Jobs

Company

Thermo Fisher Scientific
Address , King Of Prussia, Pa
Employment type FULL_TIME
Salary
Expires 2023-07-16
Posted at 11 months ago
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 analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
  • 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.
  • 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.
  • 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.
  • 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.

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

As a condition of employment with PPD, part of Thermo Fisher Scientific, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.