Job DetailsLevel ExperiencedJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Shift NightsJob Category ManufacturingDescription
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Supervisor, Fill Finish Operations in Boca Raton, FL!
The Supervisor, Fill Finish Operations position is responsible for supervising a team of manufacturing technicians and Group Leader positions producing FDA licensed final products and contract manufacturing and clinical products under GMP compliant conditions as required to meet the ADMA production plan. This position will require working an evening shift.
- Oversee the aseptic filling, visual inspection, and finishing (final packaging and serialization) of IgG and other products produced according to cGMP guidelines.
- Act as the primary lead for technical issue troubleshooting including automation and mechanical issues on highly complex equipment including the Vanrx Robotic Workcell, Vial Labeler, and packaging and serialization equipment.
- Supervise Manufacturing 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 other management members 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, 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 notification 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.
- Must comprehend and understand automation systems, 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 whenever possible and issues are properly documented.
- 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 pertinent information to subordinates.
- Assure all employees are in compliance with Standard Operation Procedures and meeting job descriptions, and ADMA 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.
- Assure that the area management is updated as to the status of the work flow, any problem areas, personnel difficulties, exceptional performance, and any operational information as required by management.
Education Requirements: Bachelor’s Degree in related field required. Bachelor’s Degree in Engineering preferred.
Experience Requirements: Minimum of 4 years in aseptic manufacturing or related manufacturing. Supervisory experience is desired. Excellent oral and written communication skills, leadership ability, good interpersonal skills, ability to coordinate and evaluate workflow, show good judgement, think independently 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.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Free shuttle to the Boca Tri-Rail station
Just awarded 2023 Best Places to Work!
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer