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Title:  Manager, CCI, P&P, 2nd shift

Requisition ID:  59850
Date:  Nov 18, 2022
Location: 

Exton, Pennsylvania, US

Department:  Laboratory
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

In this role, you will be responsible overseeing activities of the 2nd shift, CCI and Performance groups. Manage the team to assure compliance with processes and procedures to reduce risks and improve compliance and productivity.  Implement and achieve team metrics and provide directions to Supervisor of 2nd shift, Supervisor of CCI, Supervisor of P&P and Packaging and Device testing Specialist and manage their performance.  Keep current with new guidance/regulations and evaluate/implement where appropriate.

 

Essential Duties and Responsibilities:

  • Manage and provide direction and Support to the Supervisor of 2nd shift, Supervisor of CCI, Supervisor of P&P and Packaging and Device testing Specialist
  • Manage day to day activities:
    • Collaborate with Supervisor Sample and Project Planning with resource management (labor, materials, equipment, etc.)
    • Deviation Management
    • Due date compliance
    • Time Tracking Compliance
    • Performance Reviews
    • Hiring of new employees and ensuring that their qualifications and skills fit with the needs of the individual roles
    • Team metrics
  • Assure that Supervisors and analysts have been adequately trained for their role.
  • Assist in proper management of resources of the group
  • Assure due date compliance
  • Provide guidance with the development of systems for evaluation of metrics, work assignments and monitoring analyst productivity for the group.
  • Assure compliance and supervise to West and Analytical Services quality systems
  • Stay current with current technology and testing techniques
  • Support the supervisory team with protocols and reports internal and external customers.
  • Align CCI and Performance teams to provide or set industry standards
  • Align 2nd shift to meet the needs of routine extractables/leachables, CCI and Performance testing, other as appropriate
  • Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity.
  • Provide direction to the Packaging and Device testing Specialist
  • Align with industry standards for Packaging and Device testing Specialist with CCI, Performance teams
  • Support the implementation of development and validation of numerous analytical techniques. 
  • Maintain cognizance of current validation requirements.
  • Review and approve documents such as laboratory investigations, work instructions, SOP’s, etc., as assigned
  • Manage with Supervisor of Sample and Project Planning that 1st and 2nd shift resources are appropriate to meet project TAT and scope of technical work.
  • Assist and participate in audits.
  • Participate in cross functional teams as laboratory operations leads to provide input and consultation for laboratory testing and projects.
  • Hire new employees and ensuring that their qualifications and skills fit with the needs of the individual roles.
  • Keep current with new technologies and cGMP regulations.
  • Implement continuous improvement/lean activities and events for the group.

Perform other tasks as assigned

 

 

Education and Experience:

  • Bachelor’s degree or equivalent experience in chemistry or closely related field.  Graduate degree is preferred
  • 8-10 Years of experience of management experience, GMP testing, analytical testing and instrumentation

 

Knowledge, Skills and Abilities:

 

  • Awareness and understanding of the following (all skills not mandatory but preferred):
    • Container closure integrity
    • Performance and functional testing
    • Chromatography
    • Spectroscopy
    • Compendia testing
    • Testing of Syringes, vials, cartridges
    • Method development and validation
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.
  • Able to follow directions, prioritize tasks, and work independently. 
  • Must have excellent interpersonal, written and verbal communication skills. 
  • Must be proficient in Microsoft Office tools and capable to learn other software programs.
  • Able to review regulatory code and learn safety standards.
  • Occasionally come in earlier than their normal afternoon start time

 

Travel Requirements:

•            Must be able to travel up to 5% of the time

 

Physical & Mental Requirements:

•            Job-related activities that require a physical activity such as standing in laboratory environment

•            Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.

•            Employee may be required to lift heavy objects (up to 25 lbs.) without assistance

•            Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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