Quality Assurance Manager ( QA / QC)
Sterling Life Sciences - Manhattan, NY

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Partial Job Description
1) Direct and manage all aspects and functional areas of the NY Site QA Department, ensuring compliance with all regulatory and cGMP requirements
2) Provide oversight of quality functions and make quality related decisions in the areas like compounding, packaging, inspection and product disposition
3) Be accountable for the management of QA inspectors and documentation review group
4) Review and approve all deviations, non conformances, CAPAs, change controls within this functional area
5) Provides coaching, guidance and technical expertise to all NY QA personnel
6) Develop action plans to streamline and lean activities and increase efficiency
7) Establish key metrics for quantifying continuous improvement
8) Provide leadership in developing and enhancing the quality systems in the areas like procedures/best practices, equipment and process change control, process specifications and monitoring data and identification and traceability of components and finished goods
9) Support quality planning and continuous improvement
10) Adhere to 21 CFR 210, 211, 820 Regulations and ISO 9001: 2008, ISO 13485:2003
11) Identify and collect key metrics data to measure cost of quality and continuous improvement
12) Act as primary interface for ?day-to-day? quality issues for internal and external customers
13) Lead external customers audits and ensure all findings and opportunities for improvement investigated and brought to closure
14) Develop and execute all QA training and development programs, including programs that can be bridged with other functional teams (operations)
15) Identify and make recommendations for process changes that lead to measurable improvements in product/process quality and cost
16) Prepare and track financials for QA budget by overseeing expenses, over-time and by identifying and implementing efficiencies to reduce costs
17) Provide leadership in the identification of and justification for capital requests and improvements
18) Lead continuous improvement efforts, including identification of issues/non-conformances, root cause analysis and sustainable corrective and preventive action implementation
19) Ensure that documented evidence provided demonstrating that product meet release criteria
20) Collaborate with operations and R&D to ensure compatibility between process capability and finished product specifications
21) Support measurement and reporting of non - quality costs
22) Provide leadership to QA direct report inspectors and product release personnel

Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Life sciences industry experience

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