Quality Control Chemist

VARITE is looking for qualified Quality Control Chemist in Frederick, MD.

WHAT THE CLIENT DOES?

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services. Job Title: Quality Control Chemist Location: Frederick, MD Contract Duration: 4 months (Possible Extension) Pay Rate Range: $28.00/hr. to $30.07/hr. on W2 Onsite - Shift flexibility preferred Wed-Saturday: Time: Day 3PM - 1:30AM EST IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to be completed.

HERE'S WHAT YOU'LL DO

Job Description: Duties: Responsibilities (including but are not limited to): Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays. Work with internal and external resources to maintain lab in an optimal state. Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release. Maintains laboratory instruments for calibration and routine maintenance Author or revise SOPs, qualification/validation protocols and reports. Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures. Provide updates at daily and weekly meetings. Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric information for use in continuous improvement of areas of responsibility. Perform other duties as required. Basic Qualifications: Bachelor's Degree OR AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience Preferred Qualifications: Strong knowledge of GMP, SOPs and quality control processes. Identifying, writing, evaluating, and closing OOS's and investigations. Proficient in MS Word, Excel, Power Point and other applications. Strong written and verbal communication skills. Ability to communicate and work independently with scientific/technical personnel. Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). Preferred: Experience in the biotech and/or pharmaceutical industry.

BENEFITS:

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive: Health Insurance: Medical, dental, and vision coverage Retirement Plans: Participation in a company-sponsored retirement savings plan. Legal Service Plans: Offering access to attorneys for legal advice and representation. If this opportunity interests you, please respond by clicking on EasyApply. Know someone who would be perfect for this role? Refer to us and if they are hired, you could be eligible for our employee referral bonus! Help us grow our team with top talent from your network. VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Varite