QC Senior Associate
QC Senior Associate
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Salary Not Disclosed
1 Vacancy
Job Description
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 cellbased 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 inprocess release and stability testing of cell therapy products followingGMP 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 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 crossfunctional teams including Manufacturing Quality Assurance and R&D to ensure seamless of QC activities.
- Maintain laboratory equipment perform routine calibrations and ensure compliance with safety protocols.
QUALIFICATIONS:
- Bachelors degree in Biology Chemistry Biochemistry Biotechnology or a related field (Masters 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 antidiscrimination 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.
Required Experience:
Senior IC
Employment Type
Full-Time
