This position reports to the MQA Manager. This position is responsible for reviewing and releasing product, components and chemicals.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Support developing and implementing Master Batch Records for new products
Review all batch records and associated batch documentation
Provide reports on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned
Compile final batch package containing all records associated with a single batch/lot
Issue batch records to manufacturing
Create labels from LIMS for the manufacturing process
Maintain assigned operating procedures and work instructions
Compile and review all incoming material and component batch packages
Perform QA approver duties in LIMS for batch testing
Performs other related duties as assigned
Four year college degree with three to five years of related experience preferred
An Associate degree with five years of pharmaceutical experience
High School Diploma and seven or more years pharmaceutical experience
Knowledge of the CFR and other Regulatory documents is desired.
Proven oral and written communication and proofreading skills required.
Detail oriented and proficient writing, proofreading and project management skills.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.