Specialist, Quality Systems

1 week ago

Exton, United States West Pharmaceutical Services Full time

Requisition ID: 65704- Date: May 2, 2024- Location: Exton, Pennsylvania, US- Department: Quality- Description:
**Who We Are**:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

**Job Summary**:
This role is responsible for coordinating the customer specification review process among team members and performing specification reviews. Serve as a liaison with Plant Quality Managers, Sales, Technical Customer Service, customers & other groups necessary to obtain the information needed to complete specification reviews. Draft West master specifications and maintain existing master specifications.

**Essential Duties and Responsibilities**:

- Coordinate the customer specification review process
- Screen incoming specification requests for completeness.
- Maintain an accurate and current tracking spreadsheet using Excel
- Perform customer spec reviews, working with global, cross-functional groups and customers as required.
- Maintain SAP and MasterControl systems for customer specs
- Work to meet target metrics for backlog and review turnaround times
- Actively participate in process improvement initiatives
- Draft internal master product specifications for launch of new product lines; maintain/revise existing product master specifications
- Perform other responsibilities as assigned to support Quality Systems initiatives
- Assure compliance to West procedures, ISO standards, regulations and Current Good Manufacturing Practices
- Support corporate harmonization initiatives as they pertain to the quality management system
- As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems
- Work independently with supervision
- Act as a resource for colleagues with less experience.
- Other duties as assigned.

**Basic Qualifications**:

- Education: Bachelor's in scientific or technical discipline preferred. Applicable work background and experience may be considered as a substitute.
- Experience: 3-5 years

**Preferred Knowledge, Skills and Abilities**:

- Proficient in Microsoft Word and Excel, and computer systems
- Knowledge of cGMP, cGDP
- Experience working directly with customers
- Strong interpersonal, written, and verbal communications skills
- Experience with SAP and/or MasterControl.
- Experience in the medical device industry
- 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 pat all times

**Travel Requirements**:

- Minimal

**Physical & Mental Requirements**:

- 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
- Use written and oral communication skills
- 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

LI-DJ1

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

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