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 assaysPerform analytical testing on cell and viral therapy products, to verify product quality, purity, and safetyPerform 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 analysesDocument 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 PlanPaid Vacation Paid HolidaysPaid Sick TimePersonal DaysEmployee Assistance Program Life Insurance Health, Dental, Vision Long Term Disability InsuranceOther 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.