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QC Senior Associate

QPS Holdings, LLC

Springfield (MO)

On-site

USD 60,000 - 90,000

Full time

13 days ago

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Job summary

An innovative organization is seeking a QC Senior Associate to join their dynamic cell therapy team. This role is vital in ensuring the highest product quality and safety by performing a variety of analytical and microbiological assays. The ideal candidate will have a strong background in quality control, with a focus on compliance with regulatory standards. This position offers the opportunity to work collaboratively with cross-functional teams while contributing to impactful projects in the pharmaceutical industry. Join a company that values diversity, innovation, and accountability, and make a difference in improving human health.

Benefits

Retirement Savings Plan
Paid Vacation
Paid Holidays
Paid Sick Time
Personal Days
Employee Assistance Program
Life Insurance
Health, Dental, Vision
Long Term Disability Insurance

Qualifications

  • 3+ years in a Quality Control lab, preferably in cell therapy.
  • Bachelor’s degree in Biology, Chemistry, or related field required.

Responsibilities

  • Perform routine QC testing including flow cytometry and ELISA.
  • Conduct testing of cell therapy products to verify quality and safety.
  • Document all test results accurately and maintain laboratory records.

Skills

Flow Cytometry
Cell Counting
Analytical Testing
Microbiological Assays
ELISA
Molecular Assays
Aseptic Processing

Education

Bachelor's degree in Biology
Bachelor's degree in Chemistry
Master's degree in related field

Tools

GMP Compliance
GLP Compliance

Job description

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Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Stage Clinical and Phase I IV Clinical Research services. We welcome individuals who want to be part of our growing organization. QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life. QPS offers challenging and rewarding work in its four core business areas and support functions. Underpinning the operation is a culture that values diversity, innovation and accountability. Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members.

Description

The QC Senior Associate is a dynamic position that works within the cell therapy team. This role will support the testing and release of incoming raw materials and outgoing finished good/products by performing a variety of analytical and microbiological assays. This role is essential in ensuring compliance with regulatory standards and maintaining the highest level of product quality and safety.

Responsibilities

  • Perform routine quality control testing, including but not limited to flow cytometry, Cell counting, cell analyses, cell-based assays, ELISA, molecular assays
  • Perform analytical testing on cell and viral therapy products, to verify product quality, purity, and safety
  • Perform final product QC testing and release and create Certificate of Analyses.
  • Conduct in-process, release, and stability testing of cell therapy products following GMP, GLP, and regulatory guidelines.
  • Develop test methods for inspection and testing incoming raw materials and perform the analyses
  • Document all test results accurately and maintain laboratory records in compliance with regulatory requirements.
  • Participate as an analyst in MQ activities including authoring SOPs and FRMs.
  • Demonstrate aseptic processing of samples for relevant tests.
  • Assist in performing laboratory investigations related to OOS/ OOT/Abnormal analysis.
  • Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards.
  • Assist with equipment qualification, validation programs and/or performance qualification programs.
  • Ship and receive materials and samples to support QC testing and release.
  • Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, and R&D, to ensure seamless execution of QC activities.
  • Maintain laboratory equipment, perform routine calibrations, and ensure compliance with safety protocols.

Qualifications

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Biotechnology, or a related field (Master’s preferred).
  • 3+ years of experience in a Quality Control laboratory, preferably in cell therapy, biologics, or pharmaceuticals.

Outstanding Benefits

  • Retirement Savings Plan
  • Paid Vacation
  • Paid Holidays
  • Paid Sick Time
  • Personal Days
  • Employee Assistance Program
  • Life Insurance
  • Health, Dental, Vision
  • Long Term Disability Insurance
  • Other Benefits

EEO Minorities/Females/Protected Veterans/Disabled

QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Research, Analyst, and Information Technology
  • Industries
    Pharmaceutical Manufacturing

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