A2038-Manager - Quality Assurance
A2038-Manager - Quality Assurance
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1 Vacancy
Job Description
Work is typically performed under no supervision with only guidance about overall goals and objectives. Usually receives minimal guidance about how to complete work objectives. Must be able to define work based on evaluation of short term and long term goals of the department. Able to independently evaluate processes identify areas of improvement and incorporate in to overall work objectives.
- Provides ongoing leadership and support in maintaining and continually improving the site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma cGMPs 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 Quality System requirements such as ISO 9001:2015 cGMP (21 CFR Part 820) etc. including preparing for scheduling and leading annual certification compliance audits.
- Leads ongoing internal process verification audits throughout year.
- Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2015 cGMP (21 CFR Part 820)) through internal audits and analysis of site Quality Metrics data to drive continuous improvement in the QMS.
- Ensures all QMS and cGMP documents are reviewed annually and modified asneeded for ongoing compliance to company SOPs the QMS and regulatory requirements.
- 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.
- Collects and submits quality task tracker and quality metrics data for the site on a monthly basis and reports site metrics and quality data to the Platform Quality Lead.
- Interacts with customers and responsible for quality related inquiries responses to corrective action requests and facility audits as requested.
- Drives CAPA items to timely completion.
- Ensures compliance to customer requirements such as COC FAI AQL and that any deviations to specification are appropriately investigated and recorded.
- Ensures assigned programs are completed on schedule (calibration safety etc.)
- Provides leadership and direction to quality department employees.
- Participates in other activities as assigned.
Qualifications :
The duties and responsibilities described above are the essential functions of the job. The qualifications below are representative of the knowledge skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor of Science Degree with a minimum of 5 years related work experience including a minimum of 2 years of supervisory experience or equivalent experience in a comparable role.
- Advanced training or experience in ISO and cGMPs required.
- Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issues.
- Must be able to prioritize and multitask with minimal supervision.
- Strong attention to detail with excellent written and verbal communication skills.
- Knowledge of PC systems and Microsoft Office Suite (Word Excel) required.
Additional job requirements may be listed on the staffing requisition.
Additional Information :
- Quality Assurance: 5 years
- CAPA: 5 years
- FDA Regulations and Procedures: 3 years
- ISO 9001:2015: 3 years
- Supervisory: 2 years
- cGMPs: 1 year
- Printing experience strongly preferred
RRD is an Equal Opportunity Employer including disability/veterans
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
