Quality Control Analyst

QC Analyst

In the Analytical Quality Control (AQC) Lab, the QC Analyst is responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas.

Use laboratory instrumentation including but not limited to analytical equipment, autoclaves, and incubators.

Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.

Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.

Investigate nonconformances and write exception documents.

Handle multiple tasks concurrently including testing, special project / protocol testing in a timely and appropriate manner.

Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.

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

May prepare monthly quality trend reports.

Perform laboratory audits as required. Audit and update, as required, plant SOPs.

Perform test equipment, equipment maintenance and calibrations as required.

May perform other duties as assigned.

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

Minimum 1 year of related experience is preferred but not required.

Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is preferred but not required.

Basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.

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

Wet and instrumental methods of analyses (preferred)

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

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.

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

Proficient in a variety of mathematical disciplines; including ability to use statistical tools is preferred.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

Work in a cold, wet environment.

Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

Laboratory environment; inside working conditions

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.