Posted to MedZilla on 4/25/2019


Takeda Pharmaceuticals

US-CA, Quality Control Analyst II SR0032365-MZ


 
 

Conduct biological or chemical analysis on raw materials, in-process samples, final product samples or samples collected from environmental monitoring programs at Takeda manufacturing facilities. Will work under minimum supervision.

Essential Duties and Responsibilities

(List of Primary responsibilities of this role that account for 75% or more of the work. Incumbent may perform other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)

  • 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

(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.)

  • 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

(Refer to Corporate Job Descriptions for minimum requirements.)

Bachelors degree in Chemistry, Microbiology or Biological Sciences with Analytical Chemistry or laboratory coursework, with 2-5 years experience, or Masters degree in Chemistry, Microbiology or Biological Sciences, with 0-3 years experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment.

Physical Demands

(If not applicable then edit or remove)

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

(If not applicable then edit or remove)

  • 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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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