Posted to MedZilla on 2/22/2020


Takeda Pharmaceuticals

US-CA, QA Inspector II SR0046159-MZ


 
 

Summary:

Responsible for the inspection activities of chemicals and components in the manufacturing process; from quarantine to the release and/or destruction of materials. Identify defects in raw material through the inspection process. Required to sample chemicals in a classified room using appropriate gowning and safety measures. Regularly take inventory of material in non-conforming areas. Must adhere to current Good Manufacturing Practices at all times. This person is expected to participate in both departmental projects and any quality working teams which may be applicable. Continuously promote Takeda s focus on Patient, Trust, Reputation, and Business.

Essential Duties and Responsibilities:

  • Embrace the Takeda safety culture and initiatives as well as Quality Culture: Keep it simple, Take pride in doing it right, Ensure a speak-up culture and own and demonstrate your commitment to quality
  • Responsible for: Inspection and release of production materials, components, and chemicals to manufacturing facility; including Intermediate Paste shipment verification
  • Responsible for sampling Raw Materials in an ISO Classified environment; including preparation and shipment of samples to the required laboratories
  • Responsible for performing room cleaning and environmental monitoring in the ISO classified Chemical Sampling Rooms
  • Perform returned goods, product holds, and tagging and untagging of non-conforming material in a timely manner
  • Responsible for communicating with third party bonded destroyers for the destruction of Non-Conforming and rejected material
  • Responsible for appropriate storage and disposal of retention and reserve samples
  • Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support
  • Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines
  • Operate and proactively maintain laboratory and warehouse equipment. Ensure that equipment maintenance is properly documented in a timely manner
  • Support execution of validations for lab equipment, lab methods, or facility projects
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations
  • Monitor product quality through the performance of required visual and functional testing
  • Ensure the accuracy of measuring and testing equipment through the performance of calibrations
  • Promote continuous improvement through participation (i.e. team leader/facilitator or major contributor) in Quality Improvement program
  • May provide guidance and training to others
  • May perform other duties as assigned

Qualifications:

  • Strong interpersonal skills and great attention to detail are necessary

  • Must be a strong team player with good problem solving, and good verbal and written communication skills

  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices

  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner

  • Demonstrates some knowledge of assays/equipment in functional area

  • Computer literate demonstrates proficiency with typing, word processing and use of Microsoft Office programs (Word, Excel)

  • Must be able to navigate electronic mail systems and intranet for communication purposes

  • Proficient use of laboratory equipment and tools for inspection purposes

  • Must be detail-oriented, conscientious, and responsible

  • Must display an eagerness to learn and continuously improve, passion to innovate and drive for solutions, personal accountability and results for integrity, uncompromising dedication to quality, relentless focus on rapid and disciplined action, and respect for individuals and the diverse contributions of all

  • Must have effective verbal and written communication skills

  • Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement

  • Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs

  • Must be able to learn new computer systems and programs in a timely manner

  • The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements

  • General Knowledge of quarantine and warehouse operation helpful

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment

  • May be required to work flexible hours and overtime on short notice

Education and/or experience:

  • High school diploma or GED with 2+ years of experience
  • Experience in a pharmaceutical or biotech industry helpful
  • Must be familiar with cGMP and FDA requirements

Physical Demands:

  • Must be able to lift, push, pull and carry up to 50 lbs
  • Must be able to operate warehouse machinery and equipment
  • In general, the position requires a combination of sedentary work, operating machinery and equipment and standing or walking to perform inspection and release

Working Environment:

  • Office and Warehouse work environment
  • Must be able to work in controlled environments 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, contact lenses, nail polish or artificial fingernails may be worn in the work environment
  • Exposure to cold /wet /ambient warehouse environment conditions
  • May be exposed to dust, gases, and fumes (Warehouse areas)
  • May be working with or around moving equipment and machinery (Warehouse areas)
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn (Warehouse areas)
  • May be working around chemicals such as alcohol, acids, buffers and diatomaceous earth that may require respiratory protection (Warehouse areas)
  • Will have interaction with other personnel and other departments
  • Pace may be fast and job completion demands may be high
  • Must be able to work more than 8 hours a day, 40 hours a week and/or weekends as required
  • May be required to travel for business reasons, e.g. training and meetings
  • 5% travel

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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.