Posted to MedZilla on 10/14/2019


Takeda Pharmaceuticals

US-MA, Quality Control Manager - Raw Materials SR0041194-MZ


 
 

Primary Duties

Manages Quality Control specialists and technicians who perform inspection, sampling and labeling of raw materials and packaging materials. Work is performed according to established procedures to determine conformance to accepted specifications for a particular chemical attribute or physical property. Ensure the execution and maintenance of cGMP policies and guidelines pertinent to functional and departmental group responsibilities. Maintains cGMP inspection readiness and compliance at all times. Provide leadership and guidance to Technicians in all aspects of their job function.

Responsible for understanding the compendial requirements (USP, EP, JP, JPE, ACS, NF) as they relate to warehouse operations material inspection, and sampling of raw materials.

Champion for Continuous Improvement process within the department, including but not limited to daily stand up Tier Boards, 5S, Blue/Green Belt projects, and other related initiatives to support site and Operations Leadership Team sponsored goals.

Manages Quality Control specialists and technicians who perform inspection, sampling and labeling of raw materials and packaging materials. Work is performed according to established procedures to determine conformance to accepted specifications for a particular chemical attribute or physical property. Ensure the execution and maintenance of cGMP policies and guidelines pertinent to functional and departmental group responsibilities. Maintains cGMP inspection readiness and compliance at all times. Provide leadership and guidance to Technicians in all aspects of their job function.

Responsible for understanding the compendial requirements (USP, EP, JP, JPE, ACS, NF) as they relate to warehouse operations material inspection, and sampling of raw materials.

Champion for Continuous Improvement process within the department, including but not limited to daily stand up Tier Boards, 5S, Blue/Green Belt projects, and other related initiatives to support site and Operations Leadership Team sponsored goals.

Discretion/Latitude:

Work is performed without appreciable guidance. Exercises considerable latitude in determining objectives and approaches to assignments within defined procedures and practices to determine appropriate actions.

Responsibilities:

  • 65% of Time: QC Management

    Manages technicians that perform the following:

    Inspection, sampling, labeling and release of raw materials, components and packaging and labeling materials for cGMP manufacturing use. Daily review of inspection and sampling packages. Mentor and develop direct reports on cGMP guidelines, compliance, and QC functional responsibilities and tasks. Manage routine maintenance of QC equipment. Maintain raw material metrics as they relate to inspection, sampling and packaging and labeling inspection turnaround times.
  • 10% of Time: GMP quality systems; initiate, review and manage to completion deviations, CAPAs, change controls and RMNCMR s, as required. Troubleshooting of inspection and sampling atypical results and perform investigations as required.
  • 10% of Time: GMP documentation; SOP s and material specifications generation, revision and approval.
  • 10% of Time: Involvement in other QC activities as required; involvement in departmental and cross-functional teams as required on various initiatives and/or quality events.
  • 5% of Time: Regulatory and/or inspection support.

Education and Experience Requirements

Essential:

  • Position requires a Bachelor s Degree (Science-related degree is preferred) and a minimum of 8 years of related experience in cGMP biotech and/or pharmaceutical environments.

Desired:

  • Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.

Competencies:

  • Able to perform functions in accordance with cGMP guidelines. Knowledge of expectations and guidelines in current FDA & EMEA regulations.
  • Demonstrable experience managing, motivating and leading a team.
  • A high level of initiative is required
  • Excellent verbal and written communication skills are essential.
  • Strong project management and organizational skills.
  • Ability to adapt to changing priorities
  • Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint; ability to learn additional software applications, as the need arises.
  • Ability to work effectively in a fast-paced environment
  • Good interpersonal skills required
  • Ability to multi-task in a dynamic environment with changing priorities
  • Strong work ethic
  • Ability to meet challenging timelines, in spite of obstacles
  • Flexible

Key Skills:

  • TrackWise, MS Office, Compliance, Science Understanding

Adjunct Skills:

  • LIMS, SAP, EDMS, CCMS

Complexity and Problem Solving

  • Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Develop solutions to complex problems which require the regular use of ingenuity and innovation.
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Ensure solutions are consistent with organization objectives.
  • Networks with key contacts outside own area of expertise.

Internal and External Contacts

  • Frequent contact with other internal functions (e.g. QC/QA, Manufacturing, Materials Management, Facilities, Supply Chain & Procurement).
  • Represents the North Reading QC department on investigations/projects.
  • Provides support to individuals presenting during Health Agency Inspections on matters pertaining to QC Operations.

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.