AL
Quality Control Chemist - I*
Artech LLC
- 🇲🇩 Moldova
- On-site
- 12 hours ago
- $25.00 – $30.07 / hour
- calibration
- GMP
- Excel
- PCR
12 hours ago
Location - Frederick, MD, Onsite
Duration: 5 Months
Pay Range: $25/hr. - $30.07/hr.
Schedule: 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 (07:30-16:00) 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 (include 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.
Quality Control Chemist - I* · Artech LLC