We are hiring Quality Control Analyst.
Please let me know if you are interested or anyone who might be interested.
Client: Major Pharmaceutical Client
Position: Quality Control Analyst
Duration: 12+ Months Contract
Location: Thousand Oaks CA USA 91320
Pay Rate: $40.00-$62.00/ Hr on W2
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Description:
As a QC Analyst II, you will support various activities within the Quality Control department. Key responsibilities include executing analytical method transfers, including raw materials, for use in a cGMP environment. You will be responsible for conducting biological, chemical, and physical analyses on raw materials, in-process samples, drug substance, finished product samples, and other samples collected from manufacturing areas.
Essential Duties and Responsibilities:
- Conduct biological, chemical, and physical analyses on samples including raw materials, initial, in-process, and final products, as well as environmental monitoring samples, in accordance with SOPs and approved protocols
- Support implementation of new methodologies and introduction of new sample types into existing methods within the QC laboratory
- Assist in investigations of nonconformances and troubleshoot unexpected results
- Handle multiple tasks concurrently, including testing and inventory management, in a timely and organized manner
- Perform review of test data, including adherence to good documentation practices (GDP); may perform release functions in LIMS or other computerized systems
- Support generation and documentation of validation protocol deliverables
- Draft and update QC SOPs as required
- Perform equipment operation, maintenance, and calibrations as required
- Perform other duties as assigned
Qualifications:
- General understanding and knowledge of:
- Laboratory functions, test methods, and analytical equipment (e.g., HPLCs, plate readers), processes, and applicable procedures
- Laboratory safety practices, including handling of hazardous and biohazardous materials
- Wet chemistry and instrumental analytical methods
- Operating and basic troubleshooting of laboratory equipment
- General knowledge of FDA regulations, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) preferred
- Knowledge of quality and regulatory requirements related to pharmaceutical or biotechnology laboratories is a plus
- Ability to write detailed investigation reports and apply root cause analysis is a plus
- Strong team player with the ability to meet deadlines and adapt to changing priorities
- Effective communication skills with managers, peers, and cross-functional teams
- Detail-oriented with a focus on accuracy and high-quality work
- Strong interpersonal skills and ability to work efficiently in a team environment
- Ability to prioritize multiple tasks and manage time effectively
- Strong analytical thinking, problem-solving, and decision-making skills
Education and/or Experience:
- High School diploma or equivalent required; Bachelor’s degree in Chemistry, Microbiology, Biological Sciences, or a related field strongly preferred
- Minimum of 2 years of relevant work experience
- Experience in quality operations within biotechnology, pharmaceutical, or other GMP-regulated environments strongly preferred
Regards
Vishnu Das Natesan
dvishnu@radiants.com
