Manage the Preclinical Services / Pennsylvania Archives, maintain all current SOP books and historical SOP files, and maintain annual billing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Retrieval of materials in an expedient manner.
- Maintain the following archived material:
- Raw data
- Study reports
- Reserve samples
- Tissues, slides and blocks
- Secondary archive material
- Quality Assurance records
- Laboratory records
- Electronic records
- Validation records
- Maintain an index of all archived material.
- Provide orderly storage of the archived materials.
- Monitor and provide conditions of storage, which minimize the deterioration of the archived materials.
- Develop, institute, and promote business and marketing plans to support continuous revenue stream from contract archiving.
- Continuously evaluate the processes, procedures and physical requirements in support of the archive storage and retrieval and recommend any ideas that will result in improvement and/or cost saving measures.
- Evaluate available space to the projected future need and alert management to the need for additional space.
- Ship tissues and raw data to Subcontractors and/or Sponsors.
- Provide and maintain contract storage areas for other Charles River Laboratories sites and for “archive only” clients.
- Generate annual invoices for archival storage.
- Maintain and develop systems for logging, tracking and sorting archived items.
- Assist in maintaining and updating SOPs relating to the archives.
- Arrange for raw data and report conversion to microform and/or scanned storage medium.
- Perform or direct the review of new microform/scanned storage medium for accuracy and completeness.
- Perform or direct the inspection of tissues, slides and blocks.
- Perform or direct the inspection of reserve samples.
- Assist the Quality Assurance Unit in maintaining SOP books by circulating new and filing historical SOPs.
- Assist the Manager of Regulatory Compliance in all interactions with archival clients.
- Participate in the validation of electronic storage and retrieval system(s).
- Provide direct daily supervision and review work of assigned departmental employees to ensure accuracy and to ensure adherence to pertinent departmental policies, practices, and procedures [SOPs, safety procedures and bio-safety protocols.] Schedule and prioritize workload of group members.
- Assist in the interview and selection of qualified non-exempt personnel. Recommend personnel actions, including hiring, promotions and raises. Partner with Human Resources and departmental management to assist in the handling of disciplinary issues. Draft appropriate personnel action paperwork.
- Identify training and development needs of direct reports. Assist in the development, implementation and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training. Oversee maintenance of group training manual and training records.
- Monitor performance of direct reports. Provide regular coaching and counseling. Assist in preparation and delivery of salary and performance reviews of direct reports.
- Schedule overtime as authorized. Review and approve time cards. Coordinate vacation/time off schedules.
- Recommend short-range operating objectives, organizational structure of direct reports and staffing requirements. Assist in the development of a departmental plan for backup and succession of key technical personnel.
- May assist in development of departmental budget.
- Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Assist in the development, maintenance and communication of departmental systems and SOPs. Assist in the development and communication of job descriptions for subordinate positions.
- Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition.
- Perform other related duties as assigned by supervisor.
- Education: Bachelor’s degree (B.A./B.S.), preferably in a life science, or equivalent.
- Experience: Minimum of 2 years in a regulated environment. Ability to perform word processing and spreadsheet programs such as Word, Access and excel required.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certifications/Licensure : None
- Other: Must possess strong organizational and time management skills. Must be able to work as a member of a team as well as independently, with minimal supervision. Must be able to multi-task and prioritize.
Charles River Laboratories is an equal opportunity employer who values diversity in the workplace.
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