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13 Jul 2023
Full-Time Quality Operations Specialist 2nd Weekend Shift
Job Description
The Quality Operations Specialist I is responsible for performing thorough documentation review using internal procedures and controls, identifying any exceptions from approved procedures, determining disposition of material and product, executing material holds & rejects, supporting daily operations, and performing incoming inspections for excipients and components.
**Hours for this position will be Friday – Sunday 4:00pm-2:30am, Monday 4:00pm-11:30pm**
Responsibilities:
- Perform thorough documentation review using internal procedure and controls.
- Review intermediate and bulk manufacturing batch records.
- Perform real-time batch record review for final packaged, labeled product (at time of shipment).
- Review test records for drug substance, donor, and raw materials including drug substance.
- Perform label review and approval, including expiration date verification, for intermediate, bulk and finished product.
- Determine disposition of material and product.
- Create/review Certificate of Analysis
- Create Certificate of Compliance, as applicable.
- Create CTA Fax Back file for notification to Health Canada (BGTD).
- Disposition components, excipients, intermediates, drug substance and drug product
- Support daily operations.
- Issue MBRs and logbooks
- Monitor production activities and identify deviations from procedures,
- Perform investigations and partner with manufacturing to complete operational investigations.
- Own Change Controls and document updates
- Execute material Holds & Rejects
- Support other Quality Operations & Quality Systems functions as required.
Qualifications
- Bachelor’s degree in a scientific field with 2 or more years in the pharmaceutical and/or biopharmaceutical industry (or related regulated industry). Note: An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience requirements
- Preferred 1yr or more experience in a Quality role with general understanding of manufacturing processes.
- Working knowledge of cGMPs.
- Preferred working knowledge of quality regulations including 21 CFR 210, 211, 600 & 610.
- Good oral, written, and interpersonal skills, ability to function effectively in a team and manage time efficiently, customer focused approach to activities and interactions.
- Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.
- Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs, recognize variances from cGMPs, completes routine tasks with little or no oversight and requires moderate direction to complete more complex tasks.
Additional Information
All your information will be kept confidential according to EEO guidelines
How to Apply
Click here to apply| https://smrtr.io/fDVHd |
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