With over 40 years as worldwide leader in the innovation and manufacturing of cell culture media, reagents, and medical devices for researchers and clinicians working in cell therapy and regenerative medicine, is looking to identify and hire a temporary Compounder for one of their ISO certified, FDA & GMP regulated manufacturing facilities. The Compounder will weigh powder, fill, package and label containers following the lot folder instructions. There are both 1st shift (4am – 12:30pm) and 2nd shift (1pm-9:30pm) roles available.
The Compounder will be responsible for, but not limited to:
- Performing inspection of raw materials and packaging supplies for the lot; only staging the quantity of each item as per the product BOM.
- Setting up scales, calibrates and documents weighing equipment.
- Performing and documenting line clearance at the start of each packaging event
- Performing and documenting label verification prior to each labeling event; completing and documenting label reconciliation post packaging.
- Assembling buckets, boxes, bottles for packaging.
- Reviewing weigh tapes for correct weight of each package and QC sample.
- Weighing every container following lot folder and pertinent SOPs.
- Filling out all documentation real-time, accurately and legibly.
- Maintaining clean and orderly work area and performing necessary housekeeping duties.
- Assuring that correct number of samples at the correct weight are collected and logged into QC.
- Assuring packaged product is palletized, identified and shrink wrapped per SOP, and stored in the proper storage location.
- Assuring that all logbooks are maintained and that all required documentation is properly filled out in a timely manner.
- Reviewing the schedule ahead of time and performing timely staging of required materials.
- Suggesting changes in departmental Standard Operating Procedures (SOPs).
- Performing other duties as requested by Lead or Supervisor.
Requirements for the Compounder:
- High School diploma or equivalent.
- 1-2 years of experience working in a medical device, diagnostic food/vitamin processing, or pharmaceutical manufacturing company.
- Experience in an FDA regulated manufacturing environment.
- Knowledge of the metric system.
- Good understanding current Good Manufacturing Practices (GMPs) and good documentation practices (GDPs).
- Ability to lift up to 50 lbs.
**Please note that there is a no facial hair policy in the Production department.