LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Quality Control Chemist Location: Frederick, MD
Duration: 6 months Contract Payrate: $22/hr - $30/hr on W2
Onsite - Shift flexibility preferred (First 7 weeks of training M-F)
• Wednesday to SaturdaySun - Wed. 7:00am – 5:30pmDAY Shifts: 4/10 (4 days x 10 hours/day)
IMPORTANT: For the first 7 weeks of the assignment, required to work Mon-Fri (7:30 AM – 4:00 PM) to complete New Hire Orientation and Manufacturing On-boarding Technical Training.
After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete
Responsibilities:
• 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
If you have any questions, feel free to call me on
(415) 322-5419 or send an email on
akarsh.yathiraj@leadstackinc.com
Thanks and Regards
Akarsh Yathiraj |
| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 |
| W. | www.leadstackinc.com
|