Quality Assurance Area Specialist III - QA IT / Utilities

About the role

The Quality Assurance Area Specialist III (QA IT / Utilities) ensures plant systems batch release and/or relevant quality processes are compliant with regulations. They have product release authority if the role is in batch release. They oversee validation activities and documents, present and support audits and inspections, and review and approve complex Change Requests (CRs), Deviations (DVs), CAPAs, and other documentation.

Responsibilities

• Make decisions on quality & compliance issues with little guidance
• Participate in process group activities as assigned & leads local implementations
• Ensure site compliance with Regulations, ISO, ISP standards, corporate & local SOPs
• Lead improvement activities/improvements of standards within the assigned process
• Review & approve change control documentation, SOPs & other 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, QMRs & APR reports
• Eliminates non-value-added practices
• Follows all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Requirements

• High School Diploma or equivalent (GED)
• Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred
• 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
• 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
• 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

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
• 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

Benefits

Leading pay and annual performance bonus for all positions
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards

Pay

Commensurate with experience

Schedule

N/A