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POSITION SUMMARY: Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties. Participate in steering committees which originate from both corporate and manufacturing facilities. Support customer complaint data acquisition, root cause analysis and draft complaint responses. Also perform all duties associated with the auditing and documentation of compliance related items against ISO standards.
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PRIMARY DUTIES AND RESPONSIBILITIES:
- Review and approve product / process deviations or rework documentation.
- Provide quality reports and review trending on assigned areas of responsibility.
- Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any necessary records for compiling design history file.
- Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
- Meet company and departmental goals in the continuous improvement of all products, services and processes.
- Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
- Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
- Maintain information and statistics on our site’s quality performance on a monthly basis including the site’s Cost of Quality data.
- Fill in for the Quality Manager as requested or required.
- Perform DOE’s (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
- d and perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
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REQUIRED QUALIFICATIONS:
- Education: BS/BA degree preferably in a technical discipline including Business, Operations, Science
- Experience: 3-5 years of experience
- Experience using Six Sigma & SPC tools and techniques
- Experience with ISO 9000 standards and GMP’s a must
- Excellent communications (including both written & oral methods), interpersonal, problem solving (including root cause failure analysis methods), planning/organizational, negotiating and computer skills required (especially MS Office applications & statistical analysis systems); general understanding of manufacturing and plant operations are also required.
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PREFERRED QUALIFICATIONS:
- Experience with ISO 9000 standards and GMP’s.
- ASQ certification highly desired.
- Black Belt certification a plus.
- Chemistry or Engineering degree preferred.
- Graduate degree (MS) a plus.
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PHYSICAL & TRAVEL REQUIREMENTS:
- Minimal. Perform job duties as required with limited physical demands and some travel may be required.
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The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.
West Pharmaceutical Services is an Equal Opportunity Employer
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