Quality Associate Specialist, Product Release (Days)
Endo
- Rochester, MI
- Permanent
- Full-time
All incumbents are responsible for following applicable Division & Company policies and procedures.Job DescriptionScope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Supports one component of the Generics business, mainly within a single site.Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQuality Product Release
- Reviews, under close supervision, all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release
- Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed
- Confirms that all Quality events (Change Controls, CAPAs, investigations and any other documentation related to the lot to be released) are complete and closed prior to product release
- Prioritizes reviews based on production and shipment schedules
- With guidance, reviews laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepancies
- Performs MAPICS transactions to release product
- Collaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner
- Coordinates with production/ warehouse personnel to place material on Quality Hold as needed
- Follows internal processes related to controlled substances
- Follows procedures to ensure compliance to regulatory requirements
- Follows all procedures to ensure a safe and compliant work environment
- BA/BS degree in a related discipline with 0-1 year of relevant experience
- Experience in Quality Operations preferred
- Basic knowledge and ability to read and interpret SOPs and function within the scope of procedural requirements
- Knowledge and ability to work with and navigate computer systems such as MAPICs and LIMS
- Ability to handle and integrate multiple pieces of data to assure correctness
- Ability to work with cross-functional teams
- Able to recognize and identify complex errors such as calculation conversions
- Able to reconcile batch record entries with other documentation
- Proof-reading skills and ability to identify errors
- Customer/stakeholder focused, understands impact of daily work to compliance and business
- Communication skills
- Strong basic math skills
- Ability to follow complex processes
- Attention to detail
- Strong documentation skills
- Lift 15 lbs.
- Walk across plant/warehouse
- Wear appropriate gowning/PPE as required
- Ability to read for extended periods of time