Posted to MedZilla on 2/16/2020


Takeda Pharmaceuticals

US-CA, Supervisor, Quality Lab SR0045650-MZ


 
 

Summary:

Supervise, plan, organize, direct, and evaluate routine activities of Quality Control Laboratory to ensure the safety and reliability of Takeda products and to comply with quality and regulatory requirements.Support and make critical decisions for the release of raw materials, in-process production, and final release of finished products in a timely manner. Provide support for lab validations.Identify potential compliance and technical risks associated with laboratory operations and lead teams to resolve quality issues (e.g. invalid assay reducation, QC instrument lifecycle). Implement and adhere to testing standards and policies including compliance to data integrity.Manage daily operations of the lab and control of workflow to ensure operational efficiency with emphasis on results and continuous improvement. Support and drive current Quality initiatives and strategies. Drive Quality Conversations and embed Quality Culture including decision making based on Patient, Trust, Reputation and Business.

Essential Duties and Responsibilities:

  • Ensure completion of all testing, including raw materials, in-process, final release, stability, and special projects/validation testing in a timely manner that achieves fulfillment to commitments.
  • Implement and continuously improve quality systems to ensure compliance with testing SOPs and specifications along with current data integrity practices. Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems.
  • Monitor testing techniques and review accuracy of records and documentation generated.
  • Lead and/or support problem-solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Will lead complex investigations (such as CAPA, OOS or atypical test results investigations).
  • Perform routine walkthroughs and compliance checks to verify adherence to quality guidelines. Interact with inspectors in regulatory audits to represent area of responsibility.
  • Lead laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
  • Proactively lead initiatives to contribute to build a strong team and increase efficiency, solve problems, resolve operational and technical issues, generate cost savings, and improve quality.
  • Adhere to established expenditure controls to support management of laboratory budget. Support QC instrument lifecycle.
  • Ensure a safe and accountable working environment for employees by adhering to company work rules, policies, and safety standards.
  • Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans. Create performance improvement plans (PIP) where necessary.
  • Ensure employees are properly trained and/or qualified and periodically audited. Ensure personal training requirements are met and that training records are current.
  • Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
  • Ensure equipment maintenance and calibration is robust and completed on time.
  • Work with minimal Supervision to set clear direction for all direct reports consistent with departmental needs.
  • Drive Quality Continuous Improvement initiatives such as 5S, Standard Work, AGILE 4.0. along with those associated with the current Quality strategies throughout daily activities.

Qualifications:

  • Knowledge of operating and troubleshooting methods for lab equipment as well as quality and regulatory requirements pertinent to quality control of pharmaceutical and biological quality labs.
  • Must demonstrate ability to apply sound scientific principles and compliance standards to laboratory testing requirements as performed in pharmaceutical quality control laboratories.
  • Must demonstrate good Supervisory skills and excellent interpersonal skills for effective communication with subordinates, peers, and management.
  • Effective at handling and resolving personnel conflicts in a proactive manner.
  • Good leadership, organizational, and time-management skills demonstrating the ability to manage multiple projects and/or lab operations concurrently and effectively. Must be able to manage complex scenarios and continue to meet business commitments on time.
  • Must demonstrate the ability to effectively coach, mentor, and motivate direct reports, resulting in a high-performing team with a focus on results and task completion in support of operational goals.
  • Must demonstrate effectiveness in holding direct reports accountable for assigned tasks, work rules, and safety standards through a combination of positive and constructive reinforcement.
  • General knowledge of statistical techniques. Working knowledge of QSR, cGMP, CFR, USP, and GDP.
  • Demonstrate effective technical writing skills (e.g. CAPA investigation reports) and the ability to seek and identify robust mistake proofing solutions.
  • Represent the laboratory through technical presentations, management reviews, and other department presentations.
  • Computer literate and competent with a solid knowledge of word processing and spreadsheets (such as Microsoft Office). Must be capable of preparing formal presentations.
  • Proficient with a wide variety of lab application software.
  • Knowledge of applying GMP problem-solving methods.
  • Demonstration of basic project management skills.

Education and/or experience:

  • Typically requires a bachelor's degree in chemistry, biological science, or other related technical fields. 5+ years of related experience. Some leadership experience preferred.

Physical Demands:

  • Must be able to lift, push, pull and carry up to 25 lbs.
  • 20/20 near vision required (corrected as acceptable).
  • Must be able to recognize and distinguish among the colors red, yellow, and blue.
  • In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.

Working 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. This may include additional hearing protection for loud areas.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment.
  • Must be able to work multiple shifts, including weekends.
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.
  • Will work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
  • Must be able to work supplemental hours as necessary to complete work commitments.
  • Inside working conditions.
  • 5% travel as applicable.

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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