This job is currently Archived,
Posted on : 26 April 2017
- Manage and develop laboratory staff to ensure effective laboratory operations.
- Develop and implement strategies to address process improvements.
- Work with other operations staff to ensure efficient and accurate sample processing to meet customer needs.
- Ensure that all laboratory functions are carried out within regulatory and GMP guidelines in accordance with 21 CFR parts 210 and 211.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage activities of sequencing, ribotyping, and process development employees to ensure optimum performance of the group/function.
- Establish and provide continual evaluation of work procedures and processes that support company and departmental standards, procedures, and strategic directives.
- Recommend and implement process improvement methods to improve laboratory operations, efficiency and service to both internal and external customers.
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
- Collaborate with quality assurance to ensure maintenance, repair, and cleaning processes are performed on all laboratory equipment.
- Collaborate with the quality and technical operations teams to report, record, and resolve out of specification findings, deviations, and customer complaints.
- Schedule, direct, track, and document all quality control testing of raw materials and reagents. Ensure quality testing is performed in a timely fashion and designate resources to complete testing.
- Supervise and prioritize work for Process Development Technologist to ensure assay and laboratory improvements.
- Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
- Assist in the development and recommendation of departmental budget and authorize expenditures.
- Develop and oversee the implementation of departmental training programs, including orientation.
- Support the policy of equal employment opportunity through affirmative action in personnel actions.
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
- Provide support for regulatory agencies as required.
- Perform all other related duties as assigned.
- Education: Bachelor s Degree (B.A. /B.S.) in Microbiology or related discipline required.
- Experience: Six or more years related laboratory experience.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Must have good judgment, excellent communication and diplomacy skills...
- Must have strong proficiency in all technologies and laboratory techniques. Laboratory management experience strongly preferred.
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