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Specialist, Quality Systems

Company: West Pharmaceutical Services
Location: Exton
Posted on: June 12, 2021

Job 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:

This role is responsible for the coordination of the customer notification process. Responsibilities include maintaining customer notification records & documentation to demonstrate compliance to regulations & requirements. This role will ensure customer notifications regarding West's supplier changes maintain compliance with West's procedures and policies. This role will also be responsible for providing guidance, support, and training on West's change control procedures and systems.

Essential Duties and Responsibilities:

  • Performs activities for creation, issuance, and review of customer notifications with focus on Medical Device related changes.
  • Coordinate customer notification process which includes direct communication with change owners to define appropriate change notification information, impacted customers and customer approval process, if needed, with a focus on Medical Device and West Supplier changes.
  • Assist West Medical Device sites in preparation of global change requests which includes documentation of change details and ensuring harmonized approach of change implementation across like changes.
  • Coordinate activities of Change Control Review Board (CCRB) and Medical Device Change Control Review Board (MDCCRB). This includes facilitating cross functional team discussions and documentation of meeting details and outcome.
  • Maintain CCRB and MDCCRB metrics and customer notification metrics for trending, analysis, and reporting.
  • Participate in monthly change meetings with customers, as applicable, to provide information on upcoming changes.
  • Maintain the change control customer notification history, records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
  • Support initiatives for the development of digital strategies to enhance change control and customer notification processes.
  • Assist areas for training on change control and customer notification procedures and key compliance requirements as applied to West products and processes.

Basic Qualifications:

  • Education: Bachelor or Master's degree in science preferred or equivalent experience in related discipline
  • Experience: Minimum 3 years of quality related experience with preferred experience in Medical Device industry.

Preferred Knowledge, Skills and Abilities:

  • Experience in regulated industry such as pharmaceutical and medical device.
  • In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
  • Experience with SAP systems
  • Familiarity with document management databases, particularly MasterControl.

Travel Requirements:

  • Approximately 5% travel, domestic and international, if needed

Physical & Mental Requirements:

  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities
  • Position operates in a professional office environment. May stand or sit for extended periods of time
  • This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems

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 kimberley.eby@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.

Keywords: West Pharmaceutical Services, Wilmington , Specialist, Quality Systems, Other , Exton, Delaware

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