Duration : 12+ months

Description:

• As a QC Analyst II, you will support various activities within the QC department. Key responsibilities are to execute analytical method transfers, including raw materials, for use in a cGMP environment in Quality control.

• You will be responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, drug substance and final 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, and samples collected from environmental monitoring according to SOP and pre-approved protocols.

• Drive implementation of new methodologies, or new sample types into existing methods in a QC laboratory

• Support Investigation of nonconformances and troubleshoot unexpected results.

• Handle multiple tasks concurrently including testing and inventory management in a timely and appropriate manner.

• Perform review of test data, which includes overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems.

• Support generation and documentation of validation protocol deliverables.

• Draft and update, as required, QC SOPs.

• Perform test equipment, equipment maintenance and calibrations as required.

• May perform other duties as assigned.

Qualifications

• General understanding & knowledge of the following areas:

• Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.

• Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.

• Wet and instrumental methods of analyses.

• Operating and troubleshooting procedures for lab equipment

• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred.

• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.

• Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis is a plus.

• Solid team player, able to meet deadlines and changing priorities.

• Able to communicate effectively with managers, peers and subordinates.

• Very detailed oriented and able to produce high quality of work.

• Good interpersonal skills and be able to work effectively and efficiently in a team environment.

• Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines.

• Strong decision-making skills, technical problem-solving ability, and analytical skills.

Education and/or experience

• High School degree or equivalent required; Bachelor’s Degree in Chemistry, Microbiology or Biological Sciences strongly preferred

• Minimum 2 years of related work experience

• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.