Aptask Global Workforce (AGW) is seeking a Quality Control Chemist - Onsite position with a Global Biotechnology Company located in Frederick, MD. This is a 12+ month contract opportunity. This role is responsible for performing quality control testing of raw materials, intermediates, and final products within a GMP-compliant laboratory environment. The ideal candidate will utilize a variety of analytical techniques, including cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays, to ensure product quality and support manufacturing operations. For the first 7 weeks of the assignment, all contractors are required to work Monday-Friday from 7:30 AM to 4:00 PM for training; afterward, the contractor will move to their assigned shift (Wednesday-Saturday, 3:00 PM - 1:30 AM).
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 the 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
- Maintain laboratory instruments for calibration and routine maintenance
- Author or revise SOPs, qualification/validation protocols and reports
- Assist with lab investigations regarding out of specifications (OOS) results and participate in the determination of root cause for deviations
- 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
Requirements: - Bachelor's Degree
- OR AA Degree and 2+ years of experience in biotechnology or a related field and Quality Control experience
- OR High School Degree and 3+ years of experience in biotechnology or a related field and Quality Control experience
Desired skills: - Strong knowledge of GMP, SOPs and quality control processes
- Experience identifying, writing, evaluating, and closing OOS and investigations
- Proficient in MS Word, Excel, PowerPoint 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
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Experience in the biotech and/or pharmaceutical industry
Pay range: up to $30.07 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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