Quality Control Analyst II

Actual Job Title: Quality Control Analyst II

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:
o Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.
o Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
o Wet and instrumental methods of analyses.
o 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.

Physical Demand
The overall physical exertion of this position requires light to medium work.
• May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours
• May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
• May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours
• May be required to lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift
• May be required to carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to 5ft
• Requires repetitive use of both right and left hands over 4 hours
• May require simple and power grasping between 3-4 hours
• May require fine manipulation up to 1 hour
• May require pushing/pulling with hands/arms between 3-4 hours
• May require office work activities with hands/arms between 3-4 hours in all Quality areas
• May be required to gown frequently and balance when gowning into clean areas
• May be exposed to noise above 85 dBA. This may require hearing protection and other protective equipment to be worn.
• May work and have exposure to hot, cold, wet environment/conditions.
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)
• May be required to work at heights above floor level
• Will not be required to operate foot controls or repetitive foot movement
• May require the use of special visual or auditory protective equipment
• May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste in all Quality areas.
• May be required to work in confined areas.

Working Environment
• Laboratory environment; inside working conditions
• Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room environments requiring special gowning.
• May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
• May work around Methotrexate, which is a known cell growth inhibitor.
• May require immunization before performing work within the manufacturing area.
• Overtime may be required at times.
• May be required to work or be assigned to a different shift as needed.
• May be required to work weekends and holidays.