Date Posted: September 29, 2017
Job Type: Temporary to Hire
Job ID: 279929
The Quality Assurance Generalist team member will provide quality-support to the Quality department, to include oversight for adherence to cGMPs, FDA, and DEA compliance by utilizing the practices and techniques within the disciplines of Quality.
General Duties and Responsibilities:
- Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
- Reads and understands written instructions and SOPs.
- Knows and understands quality-related SOP requirements that determine appropriate process for conducting job performance.
- Knows and understands applicable regulatory requirements that impact job performance.
- Makes sure relevant activities fall within SOP and regulatory requirements to ensure product conformity.
- Prioritizes multiple tasks simultaneously & completes tasks in timely manner.
- Inspects and receives all products, components, sample, and returns.
- Determines the disposition of product and components received.
- Assist with the dis-positioning of unsaleable/unusable inventory.
- Pulls expired labeling material from inventory.
- Prepares paper bins for shredding.
- Helps with labels including insert/outsert inventory, and organization of sample totes.
- Performs visual inspection of raw material and subassemblies to assess compliance to inspection documents and other specifications.
- Requests Certificate of Analyses (COAs), Artwork, and Certificate of Releases (CORs) from manufacturers.
- Documents inspection results, organize and maintain inspection records.
- Audits Receiving Inspection processes and practices to ensure compliance to GMP requirements.
- Performs Cycle counts.
- Performs In-Process inspections
- Performs inspections and reconciliations for production runs
- Files, stores, organizes, and maintains Quality Records and Documentation
- Retrieve requested documentation in a timely manner
- Performs quality-related duties as assigned.