Microbiology Lab QCA Lead

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Microbiology Lab QCA Lead in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.

"Every vial has a name" is a core value at our Thousand Oaks CA campus, a multi-product facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Quality Control Analyst Lead.

Essential Duties and Responsibilities

• Expected to demonstrate skills and knowledge of Quality Control Analyst I.
• Use laboratory instrumentation and analytical equipment to analyze test samples. Use computer systems (LIMS) to collect and record data.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• May prepare monthly quality trend reports.
• Perform review of test data, which includes overall documentation practices (cGDP). Perform release functions in LIMS or other computerized systems.
• Maintain test equipment, equipment maintenance and calibrations as required.
• Manage multiple tasks and have ability to prioritize work load.
• In leadership focused roles, serve as a mentor to QCA I positions. Provide training, explain processes and assist in providing work direction on complex processes as required.
• Investigate complex non-conformances and write exception documents.
• Apply advanced laboratory skills to perform complex assays including special project/protocol testing in a timely and appropriate manner.
• Employee maybe 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 perform internal laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
• May perform other duties as assigned.

Qualifications

• Proficient in advanced wet and instrumental methods of analyses.
• Employee maybe 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.
• In-depth knowledge of laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
• In-depth knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• In-depth knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• In-depth knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
• In-depth knowledge of quality systems including exception management, change control, document control, etc.
• In-depth knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs a plus.
• Ability to write detailed investigation reports that consistently meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies.
• Knowledge of how to implement investigation strategies and apply root cause failure analysis.
• Strong verbal and written communication skills. Must be able to read, write, and converse in English.
• Must be a solid team player, able to meet deadlines and changing priorities.
• Must be able to communicate effectively with managers, peers and subordinates.
• Must be very detail oriented and able to produce high quality work.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
• Must have the ability to complete tasks with minimal direction from manager and/or supervisor.
• Must have the ability to prioritize multiple projects/workflow and manage time efficiently in order to meet established timelines.
• Must have decision-making skills, strong technical problem solving ability and analytical skills.
• In leadership focused roles, must have strong leadership, organizational and time management skills.
• In leadership focused roles, must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
• Must be proficient in a variety of mathematical disciplines. Ability to use and apply statistical tools a plus.
• Must be computer literate. Must be able to navigate electronic mail systems and the intranet for communication purposes. Must be able to conduct searches and fill in on-line forms on a personal computer for the purposes of training, performance management, and self-service applications.
• Proficiency with the MS Office suite of programs (including Microsoft Word, Excel and PowerPoint)
• Passion for Improving Lives. Must be able to put our patients at the center of everything we do.
• Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
• Inspired Teams environment. Must be able to thrive in diverse high performing teams.
• Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.

Education and/or experience

Bachelor's degree in chemistry, Microbiology or Biological Sciences with Analytical Chemistry or laboratory coursework, with 2-5 years' experience, or Master's degree in Chemistry, Microbiology or Biological Sciences, with 0-3 years' experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment

Physical Demand

• The overall physical exertion of this position requires light to medium work.
• May be required to sit between 1-2 hours in Micro and between 3-4 in AQC.
• May be required to walk between 3-4 hours in Micro and between 1-2 hours in AQC.
• May be required to stand for over 4 hours in Micro and between 3-4 hours in AQC.
• May be required to bend at the neck/waist between 1-2 hours in all Quality areas.
• May be required to squat between 1-2 hours in Micro and up to 1 hour in AQC.
• May be required to climb (use step stools and ladders) between 1-2 hours in Micro. Not required in AQC.
• May be required to reach above/below the shoulder between 1-2 hours in Micro and up to 1 hour in AQC.
• May be required to kneel between 1-2 hours in Micro and up to 1 hour in AQC.
• May be required to twist at the neck/waist between 1-2 hours in Micro and up to 1 hour in AQC.
• May be required to lift up to 50lbs in Micro and up to 25lbs in AQC. Lift between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift in Micro. Lifts between 5-10lbs up to 1x per shift, and 11-25lbs up to 1x per shift in AQC.
• May be required to carry up to 50lbs in Micro and up to 25lbs in AQC. Carry distance of 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 in Micro. Carry distance of 5-10lbs up to 1x per shift up to 10ft and 11-25lbs up to 1x pers shift up to 10ft in AQC. Requires use of both right and left hands and arms over 4 hours in all Quality areas.
• Requires repetitive use of both right and left hands over 4 hours in Micro and between 1-2 hours in AQC.
• May require simple grasping between 3-4 hours in Micro and between 1-2 hours in AQC.
• May require power grasping between 1-2 hours in Micro and is not required in AQC.
• May require fine manipulation up to 1 hour in all Quality areas.
• May require pushing/pulling with hands/arms between 3-4 hours in Micro and up to 1 hour in AQC.
• 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 required to drive cars, trucks, forklifts or other equipment.
• May be required to work around moving equipment and machinery.
• May be required to walk on uneven ground or slippery surfaces in Micro.
• May be exposed to noise above 85 dBA in Micro. This may require hearing protection and other protective equipment to be worn.
• May work and have exposure to hot, cold, wet environment/conditions in Micro.
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes in all Quality areas. May require respiratory protection.
• May be required to work at heights above floor level in Micro.
• Will not be required to operate foot controls or repetitive foot movement.
• May require the use of special visual or auditory protective equipment in Micro.
• May be required to work with biohazards such as: bloodborne pathogens, sewage or medical waste in all Quality areas.
• May be required to drive to travel to other facilities, training sites, and off site meetings.
• 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. Gowning procedures, wearing of protective clothing over the head, face, hands, feet, and body will be followed, and no make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in these work environments.
• Employee maybe 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.
• Must be able to read, write, and converse in English.
• Must be able to work more than 8 hours a day or 40 hours a workweek as required.
• Overtime may be required at times.
• Will be required to work an alternate work schedule (10-hour shift / 4 days a week).
• May be required to work or be assigned to a different shift as needed.
• Maybe required to work weekends and holidays.
• Will have interaction with other people.
• Pace may be fast and job completion demands may be high.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

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This job posting exclude Colorado applicants

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time