Quality Control Analyst

Takeda; Thousand Oaks (CA); On-site; USD 58,000 - 92,000; Full time

Job summary

Takeda in Thousand Oaks, CA is seeking a QC Analyst to conduct biological, chemical and physical analyses on raw materials, in-process samples and final products in the Analytical Quality Control Lab.

You will use laboratory instrumentation, ensure data integrity, compliance with FDA, GLP, CGMP, and participate in audits, trend reports, and continuous improvement.

Qualifications

• Minimum 1 year of related experience preferred.
• Bachelor’s Degree in Chemistry, Microbiology or Biological Sciences strongly preferred.
• GMP/FDA knowledge preferred.
• Strong data integrity and documentation practices.

Responsibilities

• Conduct biological, chemical and physical analyses on samples.
• Maintain data integrity and ensure SOP compliance with FDA, GLP, QSR and CGMP regulations.
• Investigate nonconformances and write exception documents.
• Prepare monthly quality trend reports.
• Perform laboratory audits and update plant SOPs.

Skills

Analytical skills

Biology knowledge

Chemistry knowledge

Team collaboration

Attention to detail

Education

Bachelor's degree in Chemistry, Microbiology or Biological Sciences

Tools

Analytical equipment

Autoclaves

Incubators

LIMS

Job description

Job Description

About the role:

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.

How you will contribute:

• 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.

What you bring to Takeda:

• 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.

Important Considerations:

• 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.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - CA - Thousand Oaks - Rancho Conejo

U.S. Base Salary Range:

$58,400.00 - $91,740.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes