Quality Assurance Manager
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Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
The Quality Assurance Manager will oversee the implementation maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. Works with site management and personnel to plan develop implement and continually improve site relevant QMS requirements and to ensure sustainable compliance to customer regulatory and RR Donnelley QMS requirements.
Responsibilities:
- Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMPs as required.
- Ensures that site QMS is in compliance with RRD QMS requirements including Quality Task Tracker and Quality Metrics reporting.
- Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008 GMP (21 CFR Part 820) etc. including preparing for and scheduling annual certification compliance audits.
- Informs site Management of significant or potentially significant quality issues and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
- Monitors and measures trends in QMS processes including GMP Quality Metrics.
- Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008 GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data.
- Collects and submits quality task tracker and quality metrics data for the site on a monthly basis and issues a report to the Platform Quality Lead
- Interacts with customers and assists with quality related responses to RFPs/RFIs for the site.
- Reviews relevant GMP documents for compliance to company SOPs quality systems and regulatory requirements.
- Leads and manages ongoing internal process verification audits throughout year.
- Ensures all deviation investigations are appropriately investigated and recorded.
- Drives CAPA items to complete and timely completion.
- Participates in other activities as deemed appropriate.
Qualifications :
- Bachelor degree in related function required
- Advanced degree strongly preferred
- 5 years related work experience
- Experience in packaging is preferred.
- Advanced training or experience in cGMPs and ISO required.
- Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue..
- Must be able to prioritize and multi-task with minimal supervision.
- Knowledge of PC systems and Microsoft Office Suite (Word Excel) required.
- Excellent written and verbal communication skills.
Additional Information :
RRDs current salary range for this role is $85000 to $136000 / year. The salary range may be adjusted based on the applicable geographic location of the hired employee and the range may change in the future. At RRD it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions may vary based upon but not limited to education skills experience proficiency performance shift and location. Depending on the role in addition to base salary the total compensation package may also include participation in a bonus commission or incentive program. RRDs benefit offerings include medical dental and vision coverage paid time off disability insurance 401(k) with company match life insurance and other voluntary supplemental insurance coverages plus parental leave adoption assistance tuition assistance and employer/partner discounts
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer including disability/veterans
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industrys most trusted portfolio of creative execution and world-wide business process consulting, with ser ... View more
