Quality Assurance Specialist

Responsible for review and/or approval of Deviations, Change Requests/SOPs, Training Material, Laboratory Investigations & Trend Reports; Supplier Program management; self-audits (in conjunction with LoB); QA presence & process confirmation on shop floor & improvement of quality processes:

• Train users & actively support IT systems which are used in collaboration with Corporate Quality Systems related to Document Management, Records Management, Change Control & Training Documentation/Support processes
• Support & implement improvement opportunities for the systems referenced above
• Support review and approve cross functional investigations and root cause analysis
• Support all Quality Management Systems (QMS) customer requests
• Train & support customers in Quality Systems owned by QMS department
• Coordinate & support business needs during audits & inspections
• Execute the document creation & revision process for various NN documentation in order to support Process Responsible, including processing SOPs, System Specifications, etc. & ownership of the electronic systems associated with documentation control
• Ensure local quality processes are in compliance with cross-functional requirements as well as regulatory requirements
• Ensure compliant execution & monitoring
• Drive corrective actions & quality improvement initiatives within production

Accountabilities

• Support incremental improvement of Quality Management Systems utilized at OFP Site Durham, such as Document Processing & Control, Records Management, Change Control, deviations, Audits & Inspections & Annual Product Review
• Implement improvements or systems identified in QMS that support departmental or customer needs
• Review & author QMS documentation, as required
• Coordinate corporate document reviews & communicate document changes (corporate & local) to site
• Control & organization of site records
• Support the site retrieval/archival needs during audits & inspections
• Support metrics for Quality System process improvements
• Provide coaching to QA Compliance & Site regarding quality-related activities
• Assist in plant-wide training on regulations, Quality systems & procedures
• Ensure site compliance with Regulations, ISO standards & corporate/local SOPs
• Review & approve change control requests
• Participate in project teams as the compliance resource
• Provide guidance to departments regarding quality-related activities
• Support, review & approve cross-functional investigations & root-cause analysis
• Participate in process confirmations & Go-Look-Sees
• Participate in knowledge & experience sharing with other QA team members to assure compliance with company procedures, policies & objectives
• Evaluate trend & report data for QMRs & APR reports
• Perform other duties as assigned
• Other accountabilities, as assigned

Required Qualifications

• BA/BS degree, preferably in a life science, engineering or related field
• Minimum of five (5) years of relevant work experience
• Knowledgeable in the following systems:  Document Management, Change Control, Deviations, Audits & Inspections & Records Management processes/databases
• Strong communication skills (verbal & written) & the ability to coach & train adult learners
• Knowledge of pharmaceutical manufacturing processes
• Strong attention to detail & excellent proofreading skills
• Strong computer skills necessary to learn & train others regarding IT systems associated with QMS responsibilities
• Willingness to learn new IT systems & develop progressive applications that improve processes & business

Desired Qualifications

Proven expertise in mentoring/development, change management, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams.