Posted to MedZilla on 2/23/2019


Takeda Pharmaceuticals

US-CA, Sr QA Technician SR0031672-MZ


 
 

This position is a Day shift position, working 4 - 10 hour days per week. The schedule is Monday, Tuesday, Wednesday and Sunday from 6:00 AM to 4:30 PM.

Responsible for performing the day-to-day quality operations (QA Inspection) for QA Filling/Finishing within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines and Shire quality practices.

Essential Duties & Responsibilities

Responsibilities include, but are not limited to:

  • Oversight/Monitoring of aseptic technique during filling operations.
  • Issuance/Reconciliation of labeling for packaging operations.
  • Managing of labeling material in warehouse.
  • Perform visual inspection and AQL sampling of final container vials.
  • Perform AQL sampling of final packaged product.
  • Operate Forklift.
  • Perform tagging and un-tagging activities for quarantined material.
  • Perform JDE inventory transactions.
  • Participate on Continuous Improvement Teams.
  • May perform other duties as assigned.

Qualifications

  • Knowledge of good aseptic techniques/practices.
  • Knowledge of cGMP.
  • Knowledge of Code of Federal Regulations 21 CFR - Parts 210 & 211.
  • Must be able to read, write and converse in English.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Must be able to navigate, conduct searches, and fill on line forms on personal computer for the purposes of training, performance management, and self service applications.
  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Batch Record Review.

Education and/or Experience

Requires a BA/BS with 0-2 years related experience or AA/AS degree with 1- 3 year(s) related experience or a High School Diploma with 2 - 4 years related experience. Experience in biotech industry within Filling/Finishing areas desirable.

Working Environment

  • Must be able to work in controlled clean room environment requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands feet and body. No make-up, jewelry, nail polish or artificial fingernails may be worn in the work environments.
  • Must be able to work a 4/10 day which may include a split shift schedule. One weekend day would be required.
  • Overtime may required at times. (Including holidays if required)
  • Will have interaction with other people.
  • May be required to work or be assigned to a different shift as needed.
  • Will have interaction with other people.
  • Pace may be fast and job completion demands may be high.

Physical Demand

  • Physical Demand Level - MEDIUM.
  • Rarely Lifting - Up to 50 pounds.
  • Occasional Lifting 13 - 15 pounds.
  • Frequent Lifting - up to 13 pounds.
  • Standing - Frequent - Function performed as employee supervises and assists in manufacturing areas. Total standing and walking can be up to 7 + hours in an 10 - hour workday.
  • Walking - Frequent.
  • Sitting - Frequent - Production of reports and internet, telephone communication.
  • Pushing/Pulling - Required in some positions to inspect equipment, access alternative areas of facility.
  • Climbing - Occasional.
  • Overhead reaching - Frequent - to obtain and place materials for inspection or reach needed materials.
  • Kneeling- Occasional - To observe materials and equipment at floor level. Crawling - Rarely.
  • Hand/Finger Feel - Frequent - Employees are required to handle the individual packages and handle small fine parts. Parts will have multitudes of textures and sizing. Employees will be required to use fine manipulation for a multitude of tasks.
  • Gripping/Grasping - Frequent - Employees are required to use hand tools and possible other equipment to assist in the manufacturing and quality assurance of products.
  • Drive - Rarely - as to non-commercial motor vehicles.
  • Communication - Constant - Employees must be able to communicate orally and in writing in a clear, concise understandable manner to supervisor and instruct co-employees and staff. Including use of computer, telephone and related communication instruments.

Definitions:

Rarely: 1-5 percent of the time in a ten hour day

Occasionally: 6-32 percent of the time in an ten hour day

Frequently: 33-66 percent of the time in an ten hour day

Constant: 67-100 percent of the time in an ten hour day

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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