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QA Oversight Specialist_Weekdays Mon - Wed & EO Thurs
Jubilant Bhartia Group - Spokane, WA
posted about 1 month ago
About the position
The QA Oversight Specialist provides support to all functions associated with manufacturing and quality control operations via daily on-the-floor support. The oversight includes evaluation and review of ongoing Manufacturing and Quality Control Operations, and management of all Quality functions related to facility, systems, and manufacturing support. Other areas include (but are not limited to) Metrology, Engineering, Maintenance, and Information Systems (IS).
Responsibilities
- Ensure that all applicable US and European regulatory requirements are being met within the procedures and practices of the Manufacturing and Quality Control units.
- Conduct on the floor oversight of the Manufacturing and QC facilities to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP).
- Provide necessary daily, weekly and monthly summaries and reviews for on the floor observations, provide responses to observations and ensure that all corrective action measures are completed as described and within the timeframe given in the response.
- Recognize potential problems and review and approve proposed mitigations, or document problems encountered, collaborating with department supervisors to ensure that quality requirements are clearly communicated to resolve any deficiencies in product quality or manufacturing systems and procedures.
- Ensure that investigations related to deviations in facility or support systems are complete and adequate.
- QA oversight of aseptic processing.
- Assist in training of any new QA Oversight personnel.
- Provide review/approval on Quality system records.
- Seek continuous improvement by revising SOPs related to job function in order to meet industry standards.
Requirements
- Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degree.
- Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience.
- FDA regulated industry experience required.
- Proficiency In Microsoft Word, Excel And PowerPoint Required.
- Mechanical Aptitude Desired.
- In-Depth Understanding of the Relationship between Regulatory Requirements, Operating Procedures, and Ensuring Compliance in a Production Environment required.
- Able to Follow Detailed Instructions required.
- Exposure to allergens, working in Aseptic areas, and prolonged sitting and standing required.
Nice-to-haves
- Mechanical Aptitude Desired.
Benefits
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
- Voluntary Life and AD&D for employee & family
- Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
- Pet Insurance
- ID Theft Protection
- Perk Spot Discount Program
