This shift is Sunday - Wednesday 5:30 AM - 4;00 PM 4/10 schedule
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
In this role you will be responsible to independently provide analytical review of the data generated for internal and external customers as well as supporting post-production related Quality activities such as finished batch release, including sterilization, packaging specifics, work order approval and support additional quality department activities. This position also requires maintaining knowledge of the current local and/or International regulations/guidelines/policies applicable to West's products and services.
Essential Duties and Responsibilities
- Assist and directs the activities and resources of Quality Tech group including; work assignments, break scheduling and relief
- Coordinates with other departments to ensure variety of QA support
- Assist with coordination of training and coaching to QA Techs to ensure quality standards and maintained.
- Inspects and release incoming materials. May perform analytical testing, evaluates, records and reports on the chemical and physical properties of various substances and materials to determine product release approval status.
- Review and approve Batch Production Records from each job.
- Compose Non-Conformance Report (NCR) Deviations, Document Change Notices (DCN), Out of Specification(OOS), Work Instructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).
- May create protocols for validation of analytical procedures, perform the validation, calibrate gauges and write reports.
- May compose protocols for Installation Qualification/Operational Qualification (IQ/OQ) of various equipment, perform IQ/OQ.
- Assist in the design & drawing reviews and make recommendations for improvements, clarification, and correctness as needed.
- Assists shift personnel with quality issues and/or measurement techniques.
- Input incoming lots into expiration/retest database.
- Maintain expiration/retest date database for incoming materials. Review retest dates and arrange for testing of materials for retest. Review expiration dates and arrange for disposal of expiring materials.
- Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
- Maintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMS
- Collaborate as needed on proposed path forward regarding documentation questions
- Other duties as assigned
Additional Responsibilities
- Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Maintain a clean, orderly, and safe workstation and environment at all times.
- Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
- Exhibit regular, reliable, and punctual attendance.
- Perform other duties as assigned based on business needs.
- Keep current with new GMP compliance guidance and internal QA procedures
- Support new GMP compliance guidance and Data Integrity initiatives
Education
- High School or Equivalent
Preferred Knowledge, Skills and Abilities
- Able to be aware of all relevant standard operating procedures as per Company policy
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
- Willingness to learn new and review new analytical techniques
- Meet individual and departmental goals as required
- Able to always comply with the company’s quality policy.
- Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
- Must be able to prioritize and perform position responsibilities accurately and meet required deadlines.
- Strong attention to detail; Strong problem identification/analysis and solving skills with hands-on approach.
- Excellent verbal and written communication skills; Maintain an organized and clean quality Lab.
- Ability to multi-task and prioritize in a fast-paced environment; Ability to interface with all personnel levels.
- Motivated self-starter with ability to work independently on multiple assignments in a team environment.
License and Certifications
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
- Ability to learn, understand, and remember normal tasks.
- Ability to hear, speak, and understand conversation in English in a normal tone of voice.
- 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.
- Read and interpret data, information and documents
- Work under deadlines with constant interruptions
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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