Quality Control Analyst - GMP/Pharma

Insight Global; Malvern (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the biotechnology sector is looking for a Quality Control Analyst to join their team in Malvern, PA. This role involves conducting biochemical testing in compliance with GMP regulations and collaborating with a dedicated team. The ideal candidate should have a degree in Biology or Chemistry, along with relevant experience in QA/QC procedures. Benefits include 10 PTO days, sick days, and comprehensive healthcare coverage.

Benefits

10 Days of PTO

6 Sick Days

Paid Holidays

Healthcare benefit packages

401k with employer matching

Qualifications

• Minimum one year of relevant GMP QC work experience.
• Working experience in a cGMP compliant QC laboratory is required.
• Proficient with MS Office applications.

Responsibilities

• Conduct analytical biological testing of clinical and commercial drug products.
• Perform peer reviews and approvals of laboratory data.
• Support New Product Initiatives and perform project management.

Skills

GMP QC experience

Analytical testing

Technical document interpretation

Statistical analysis

Education

Bachelor degree in Biology or Chemistry

Tools

Microsoft Office

LIMS

Empower

Job description

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.78/hr - $41.87/hr

Direct message the job poster from Insight Global

QUALITY CONTROL ANALYST - CLINICAL RELEASE AND STABILITY

10 Days of PTO / 6 Sick Days / Paid Holidays

Fully Onsite Located in Malvern, PA

Compensation:

$35.78/hr to $41.87/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Required Skills & Experience

-Minimum one year of relevant GMP QC work experience in Pharmaceutical lab -Bachelor degree in Biology or Chemistry -Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs) -Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISA -Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols -Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

Nice to Have Skills & Experience

-CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience

-Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC

-Ability to complete equipment and software qualification protocols

-Experience developing and setting long-term objectives

-Experience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facility

-Knowledge of EU/FDA guidance

Job Description

The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.

Key Responsibilities:

-Conduct analytical biological testing of clinical and commercial drug product/drug substance samples

-Perform peer reviews and approvals of laboratory data

-Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data

-Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management

-Perform Instrument Calibration and Preventative Maintenance

-Update CRS-owned documents using the Document Management System (DMS)

-Order/receive supplies and manage inventory

-Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities

-Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight

-Act as a peer subject matter expert in assessing talent by participating in panel interviews for job

-Complete invalid assay and general laboratory investigation records

-Complete corrective and preventative actions (CAPA) as assigned

-Assist in the execution of internal audits

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Science, and Analyst

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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