QA Area Specialist III - Finished Production (Validation Focus)

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Generous paid time off including 14 paid holidays

Health, Dental, and Vision Insurance

Tuition Assistance

401K with employer contribution

Job summary

Initial Therapeutics, Inc. in Clayton, NC seeks an experienced QA professional to support Finished Production. You will ensure compliance with regulations, oversee quality processes, and make key decisions in quality management.

Successful candidates will have at least seven years in QA, experience in cGMP environments, and expertise in regulatory quality systems. This role offers a dynamic workplace with leading pay and comprehensive benefits from day one.

Qualifications

• Minimum of seven years of QA experience in manufacturing
• Experience with regulatory requirements and cGMP practices
• Excellent written and verbal communication skills

Responsibilities

• Ensure compliance with quality processes and regulations
• Review and approve change control documentation and quality documentation
• Provide coaching on quality and compliance activities

Skills

Expertise in Regulations & quality systems

Excellent troubleshooting skills

Demonstrated knowledge of cGMP documentation practices

Leadership in improvement activities

Education

Bachelor’s degree in Life Sciences

High School Diploma or equivalent

Tools

Quality Risk Management tools

LEAN and Six Sigma methodologies

Job description

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What We Offer You

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• 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

The Position

This 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.

Relationships

Reports 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, ISO/ISP 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 Requirements

Moves 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 require 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.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.