The PositionThis role supports our Finished Production area with a focus on review of validation activities. Ensures plant systems batch release, and/or relevant quality processes are compliant with regulations. Has product release authority if role is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Presentation, support & coaching for audits & inspections. Review & approval of complex Change Requests (CR's), Deviations (DVs), CAPAs & other documentation. Performs Self Audits (in conjunction with line of business (LoB)); Quality Assurance (QA) presence & process confirmation on shop floor. Site Clayton Process Representative, as assigned. Able to support all processes & functions in Department. Trends and reports data as applicable. This role requires prior experience in a GMP environment. This is an onsite based role Monday-Friday.
RelationshipsReports to: Associate Director, QA Finished Production.
Essential Functions- Make decisions on quality & compliance issues with little guidance
- Participate in process group activities as assigned & leads local implementations
- Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)
- Lead improvement activities/improvement of standards within the assigned process
- Review & approves change control documentation, SOPs & other current good manufacturing practice (cGMP) documentation
- Provide coaching to Site regarding quality & compliance related activities
- Supports, reviews & approves complex cross-functional investigations & root-cause analysis
- Facilitates sharing of regulatory & compliance expectations
- Reviews & approves complex DVs, CRs, (SOPs), trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports
- Eliminates non-value-added practices
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Qualifications- High School Diploma or equivalent (GED) required
- Bachelor's degree in Life Sciences or a relevant field of study from an accredited university preferred. ***If hired as a AQP, Bachelor's degree in Life Sciences or a relevant field of study from an accredited university required
- Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field required
- Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred
- Quality Risk Management experience required
- Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required
- Experience in use of Risk Assessment & Vendor Assessments during evaluation of change controls, deviation and validation activities required
- Expert in cGMP documentation practices. Requires a minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred
- Excellent troubleshooting skills; able to identify root cause of problem required
- Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferred
- Excellent written & verbal communication skills required
- Auditing experience with certification preferred (internal/external) required
- Experience with LEAN, Six Sigma & other continuous improvement methodologies required
- Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred
- Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required
- Expert in utilizing appropriate root-cause analysis tools & techniques preferred
- Experience with Risk Assessment & Risk Management required
- Demonstrated excellence with time management, organizational & project management skills required
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
