Oversee the manufacture of IgG plasma fraction and / or bulk products and intermediate pastes within cGMP guidlines.
Supervise Mfg Technician and Group Leader positions. Manage requests for time off. Prepare annual performance appraisals and recommend salary increases. Review and approve time cards to ensure compliance with attendance policy. Handle disciplinary measures for staff as well as promotion recommendations. Interview and participate with managers in hiring staff.
Provide on the job training, technical training, assessment of progress and coaching. Work with trainers to assure development of proper work and documentation practices and identification of specific individual training needs for all team members.
Maintain a clean, GMP compliant and safe working environment.
Assure timely and accurate initiation and completion of quality system documents (deviations, CAPAs, Change Controls, Temp Variances, etc) as assigned / required.
Provide shift leadership and sound judgement and decision making regarding quality, processing, capacity, personnel, and any other issues as they arise with appropriate consultation with and notifcation to management.
Take ownership of and responsibility for the area, facilities, equipment and processes during shifts. Assure facilities and equipment are operated, cleaned and maintained at a GMP compliant level.
Prepare team and individual work schedules and coordinate assignments to maximize production efficiency while maintaining high quality and documentation standards . Coordinate personnel and resources on a day to day basis to accommodate the work schedule.
Coordinate related work and scheduling with other departments including but not limited to Warehouse, Plasma Ops, QC,QA, PD, Eng Facilities, EHS, IT, Finance and HR.
Evaluate work load and assign tasks to technicians on a daily basis.
Must comprehend and understand automation systems (PAS), CIPs, HMIs, etc and possess mechanical aptitude to troubleshoot the type of problems associated with departmental processes and equipment.
Prioritize work based on production schedule and meet deadlines.
Assure that all appropriate logs and batch records are completed accurately and in a timely fashion per appropriate SOPs.
Troubleshoot work related problems to ensure that delays are avoided.
Assure that raw materials that are needed for production are available in a timely manner so that adequate supplies are available to avoid production delays.
Protect integrity and quality of product, elevating problems appropriately to management as needed to assure production decisions are made at the proper level.
Be capable of reviewing both corporate policies and technical procedures, and successfully train and/or communicate pertient information to subordinates.
Assure all employees are in compliance with Standard Operation Procedures and meeting job descriptions, and Biotest policies and procedure requirements.
Administer and prioritize any changes necessary to comply with personnel policies and procedures and Standard Operating Procedures as established by the company. Review new and revised procedures before they are finalized.
Establish and monitor new employee training and verify appropriate new employee documentation is complete and properly filed. Assure proficiency testing for employees are up-to-date. Ensure consistent training and operational practices between shifts. Assure that the Department Managers, are updated as to the status of the work flow, any problem areas, personnel difficulties, exceptional performance, and any operational information as required by the Manager.
Day and Evening shift positions available.
Education Requirements: Bachelor Degree in related field preferred. (Plasma Product Mfg experience at Tech III / Group Leader equivalent experince or higher can offset education requirement).
Other Essential Knowledge: Excellent oral and written communication skills, leadership ability, good interpersonal skills, ability to coordinate and evaluate workflow, show good judgement, think independantly and make decisions; ability to negotiate with and mentor employees; good computer skills; and knowledge of control system operation; excellent problem solving ability and comprehension ability as well as basic mathematical computation skills including algebra and geometry.
Minimum of 4 years in Plasma Product manufacturing at a tech III level (or higher) or related manufacturing and supervisory experience desired.
Biotest Pharmaceuticals - 5 months ago