QA Specialist
- Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.
- Prepare CofC and CoAs.
- Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.
- Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.
- Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.
- Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department.
- Review and approve Stability Studies protocols and reports.
- Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions.
- Support the Audit Team with during external and internal audits.
- Provides support to the program management office with the review and approval of the design transfer package documentation.
- Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives.
- Preferred BS in Engineering, Biology, or other technical related degree
- A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations.
- Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
- Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
- Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility.
- Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations.
- Knowledge of Good Manufacturing Practices & Good Documentation Practices
- Able to communicate effectively and work within cross-functional teams.
- Excellent oral and written communication skills with strong technical writing experience required.
- Experience in internal / external audits, identify findings, drive resolution, and provide closure report
- Proficient skills in solving complex problems and ability to bring issues to resolution.
- Experience working globally with diverse teams and cultures
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
Recommended Jobs
AI Automation Engineer (Agentic Workflows) + Technical SEO/AEO
Engagement: Â Project-based (strong potential for extension) Location: Â Surfside, FL (onsite only; private office) Schedule: Â Flexible ~ Full-time (40 hrs/week), or ~ Part-time (3 days/we…
Sales Administrator
Work Opportunity: Sales Administrator
Part Time Meat Cutter
Join our team as a Part-Time Meat Cutter in Cape Coral, Florida! Responsibilities Cut, trim, and prepare meat products to meet quality standards Maintain cleanliness and sanitation of work are…
OTR CDL Class A Solo Truck Driver
DSL Express and partners now hiring Class A CDL Solo Truck Drivers for OTR! Company drivers with 2+ yrs of experience and a decent MVR/PSP score. Position available ASAP. Pay is performanc…
Field Sales Representative
Omada.ai is hiring ambitious field sales reps to introduce local businesses to our AI marketing platform. This isn't just another commission-only gig—we pay you $25/hour guaranteed ($1,000/week at 4…
Interior Designer I
POSITION SUMMARY: Plans, designs, prepares interior design construction documents relating to additions, alterations and renovations. Reviews performance of existing materials and provides direct…
Physician - Pediatric Anesthesiologist
Johns Hopkins All Children’s Hospital is seeking a highly skilled and compassionate Pediatric Anesthesiologist to join our dedicated team at Johns Hopkins All Children’s Hospital. In this role, you w…
Sales Coordinator (Full-Time) | InterContinental Miami Downtown
About us: As the world's largest family of luxury hotels, we all take great pride in being genuine ambassadors of the InterContinental® brand. Shaped by decades of international know-how and local…
Senior Generator Technician
Reports To: Service Manager / Director of Service Operations Role Summary: The Senior Generator Technician is a top-level field expert responsible for diagnosing, repairing, maintaining, and c…
Procurement Manager
At Churchfront, we believe technology—when paired with timeless truths—can unlock new potential in ministry. We're a national AVL integrator, media platform, and education resource serving churches a…