Manufacturing Systems Supervisor, Fill Finish Operations

Location
Boca Raton, FL
Posted
Jun 08, 2021
Ref
26753
Required Education
Bachelors Degree
Position Type
Full time

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 Manufacturing Systems Supervisor, Fill Finish Operations in Boca Raton, FL!

 

This position supervises a portion of fill finish operations and is the lead for internal Fill Finish quality system activities including deviations, CAPAs, and Change Controls.  This role will provide supply chain oversight of quality activities at contract manufacturing sites and distribution facilities. 

 

ESSENTIALS OF THE JOB

  • Oversee the aseptic filling, visual inspection, and finishing (final packaging and serialization) of  IgG and other products produced according to cGMP guidelines.
  • Provide shift leadership and sound judgment and decision making regarding quality, processing, capacity, personnel, and any other
    issues as they arise with appropriate consultation with and notification to management. 
  • Assure timely and accurate initiation and completion of quality system documents (Deviations, CAPAs, Change Controls, complaints
    etc.) as assigned/required for internal and external filling, finishing, and distribution working in close collaboration with Quality and Regulatory.
  • Supports and participates in shipping validations for all shipping lanes from plasma shipments, bulk, and finished goods from CMO.
  • Support the preparation, execution, and review of batch records, protocols, and qualification documents for the fill-finish area.
  • Prioritize work based on the production schedule and meet deadlines.
  • Utilizes SAP modules to execute required functions.
  • Maintain a clean, GMP compliant, and safe working environment.
  • 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.
  • 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.
  • Protect integrity and quality of product, elevating problems appropriately to management as needed to assure production decisions are
     made at the proper level.
  • Assure all employees comply 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.
  • Participate in special projects as required.
  • Travels occasionally to audit CMO’s, transportation suppliers, and distribution centers.

 

Qualifications

Education Requirements:                 

Bachelor’s Degree in related field required.  Bachelor’s Degree in Engineering preferred.

 

Experience Requirements:                

Minimum of 5 years in GMP manufacturing-related position preferably including aseptic filling and finishing.  Significant working experience using quality systems including deviations, investigations, CAPAs, and change controls.

 

Other Essential Knowledge:                                                                                                                             

Excellent oral and written communication skills, leadership ability, good interpersonal skills, ability to coordinate and evaluate workflow, show good judgment, 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
  • Company paid shuttle to the Boca Tri-Rail station

 

 

ADMA Biologics, Inc. 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