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.