Contract position: First and second shift positions available for a Quality Analyst II in Bloomington IN. Selected candidates will be a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Review. He or she performs review of all quality documentation generated during filling operations. He or she must communicate effectively with production and customer support departments to coordinate batch review activities to meet internal commitments.This is a contract position expected to last 12 months, could be longer based on performance. Great Contractor Benefits! Apply Now!Responsibilities for the Quality Analyst
Requirements for the Quality Analyst
- Perform batch record review for GMP batches for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
- Reconcile discrepancies with documentation and/or electronic systems as appropriate.
- Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
- Performs Quality review in classified areas, reports errors, deficiencies, discrepancies and observations to management. Expected to escalate when product safety is or may be compromised.
- During in-process review, ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.
- Bachelor's degree in a science discipline or Bachelor's degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.
- Knowledge of cGMP manufacturing.
- Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.