Records Specialist

Records Specialist JOB SUMMARY: Responsible for the storage, archiving, copying, and retrieval of all equipment-related documentation located in the Engineering Library, as well as any documentation stored in an off-site location. This position will manage library systems to ensure that compliance with company and regulatory policy is maintained, to include designing filing systems, both paper and electronic, and auditing records as necessary to ensure accuracy. Participation is required for all cGMP-related inspections and all internal and external audits to facilitate document availability for review.

JOB ACCOUNTABILITIES:
Maintain the library records management systems in a compliant state by continually assessing compliance to site, company, and regulatory requirements, and modifying systems, both paper and electronic, as necessary.
Perform storage, retrieval, archiving, and copying of all documentation located in the Engineering Library and off-site locations as necessary
Direct activities for personnel assigned to the Engineering Library and ensure accurate and timely task completion to maintain required documentation compliance.
Ensure required documents are available for both internal and external audits and investigations.
Train library personnel for file maintenance, customer service, and other tasks as necessary to ensure library is maintained in a compliant state.
Support projects assigned to the Engineering Library as directed.

EDUCATION/EXPERIENCE/REQUIREMENTS:
BA/BS degree in Library Science, Information Science, Business Administration, Computer Science, or related field with 5-7 years experience in a regulated environment or MS degree in Information Science, Library Science, ore related field with 3-5 years experience in an FDA regulated environment.
Incumbent must have library/records management experience. Must have strong organizational skills, be very detail-oriented, have good interpersonal and communication skills, both written and oral. Assertiveness, diligence and diplomacy are required. Highly prefer experience in an FDA-regulated environment.


Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.

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