Supervisor, Visual Inspection Operations

1 month ago

Boca Raton, United States ADMA Biologics Full time
Job DetailsJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Shift DayJob 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 have an exciting opportunity for a Supervisor, Visual Inspection Operations in Boca Raton, FL

 

The Supervisor, Visual Inspection Operations is responsible for supervising and maintaining the qualification of manual visual inspectors for manufacturing personnel and MQA personnel.  The visual inspection process is a critical step in 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 on a day/evening shift.

 Qualifications

ESSENTIALS OF THE JOB:

Oversee and participate in the visual inspection qualification process which includes scheduling, training, documentation of the visual inspection program and visual inspection of product. Act as the primary lead for visual inspection including automation, mechanical, procedural or particle issues during visual inspection of product or media filled vials.  Supervise multiple positions, manage requests for time off, prepare annual performance appraisals and recommend salary increases. Review and approve timecards 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 other trainers to ensure development of proper visual inspection technique and documentation practices and identification of specific individual training needs for all team members. Assist and participate in the labeling/packaging and serialization of final product vials. Maintain a clean, GMP compliant and safe working environment. Ensure timely and accurate initiation and completion of quality system documents (Deviations, CAPAs, Change Controls, etc.) as assigned / required. Provide 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 visual inspection areas, particle libraries, equipment and processes during shifts. Ensure rooms and equipment are operated, cleaned and maintained at a GMP compliant level. Prepare team and/or individual training/qualification schedules and coordinate trainings/qualification 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. Ensure that all appropriate logs and records are completed accurately and in a timely fashion per appropriate SOPs. Ensure that materials that are needed for visual inspection are available in a timely manner so that adequate supplies are available to avoid delays. Protect integrity and quality of product, elevating problems appropriately to management as needed to ensure 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. 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. Ensure all employees are in compliance with Standard Operation Procedures and meeting job descriptions, and ADMA policies and procedure requirements. Ensure that the area management is updated as to the status of the workflow, any problem areas, personnel difficulties, exceptional performance, and any operational information as required by management. Perform other duties as assigned.

Education Requirements: 

High School Diploma or GED. Associate degree or equivalent experience preferred.

Additional Experience Information: 

Minimum of 4 years in visual inspection processes or related manufacturing experience. Supervisory experience is desired.

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

 
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.

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