- Coordinates sampling of incoming raw materials and provides samples to QC labs for testing and release.
- Coordinates sampling and performs testing of incoming components (i.e. vials, stoppers, seals); this includes coordinating sending samples to contract labs as needed.
- Inspects and releases labels and packaging materials; this includes performing counts of labels using the label counter machine.
- The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
- Perform monitoring of non-sterile powder filling operations which includes line clearance and release.
- The job responsibilities require the ability to lift, push, pull and carry up to 50 pounds; it requires a combination of walking around the facility along with sedentary work.
- Document work in master production records, logbooks, data sheets, as applicable.
- Perform status change in QAD for release of raw materials, components and labels.
- Participate and write environmental notifications and deviation investigations, as applicable.
- Prepares paperwork and labels for samples and provides respective specification sheets with samples submitted to QC lab or Microbiology for testing.
- Prepare and revise standard operating procedures.
- Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
- Perform Line clearance and Line release for manufacturing.
- Perform Product Hold/ Product disposition.
- Train personnel for tasks mentioned above.
- Perform investigations.
- Oversees sample retention program.
- Prepares CofA.
- Modify procedures as needed.
- High school diploma/GED required, Bachelor's degree in Sciences preferred
- Minimum of 1-3 years in a manufacturing environment with familiarity with cGMPs. Pharmaceutical manufacturing experience preferred.
- Good aseptic techniques, documentation skills, and computer skills. Aseptic gowning qualification a plus.
- Self-initiating and self-directed, strong collaboration skills with other departments (i.e. production, quality control, validations), ability to manage competing priorities, and an ability to communicate and defend quality initiatives and compliance.
- Ability to speak and write English (English and Spanish a plus).
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com