Quality Assurance Area Specialist Iv

10+ years

Not Disclosed

Durham Remote United States

10 Feb. 13, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance Area Specialist IV
Location: Clayton, United States
Job Category: Quality

The Position

The Quality Assurance Area Specialist IV is responsible for ensuring compliance with regulations (e.g., 21CFR part 211) related to plant systems batch release and other quality processes. This position also involves overseeing quality-related activities including validation processes, managing quality oversight, and serving as the subject matter expert for Asceptic Processing (AP) or other processes at the site. The role requires leadership in improving processes based on performance and driving continuous improvement using LEAN principles.

Relationships

Reports to: Senior Manager, Quality Assurance

Essential Functions

Quality and Compliance Decision-Making:
- Make decisions on quality and compliance issues with minimal guidance.
- Lead and participate in process group activities and local implementations.
- Ensure site compliance with Regulations, ISOISP standards, corporate, and local standard operating procedures (SOPs).
Subject Matter Expert (SME):
- Serve as the SME for multiple quality processes and systems.
- Lead improvement activities and the standardization of processes within assigned areas.
- Serve as a (AP) subject matter expert for QA processes and drive improvement activities based on process performance.
Batch Release and Documentation Review:
- Lead and coordinate batch release activities.
- Review and approve complex DVs, CRs, SOPs, and trend data related to CAPA, Quality Management Reviews (QMRs), and Annual Product Reviews (APR).
- Eliminate non-value-added practices.
Investigations and Audits:
- Support, review, and approve cross-functional investigations and root-cause analyses.
- Facilitate and support audits and inspections, offering coaching to the site on quality and compliance-related activities.
- Perform self-audits and process confirmation on the shop floor.
Regulatory & Compliance Oversight:
- Serve as the quality work package owner or approver of validation documentation.
- Provide coaching and facilitate sharing of regulatory and compliance expectations across teams.
- Serve as a Quality Risk Management Expert and lead training activities.
Additional Duties:
- Perform other accountabilities as assigned.

Physical Requirements

Ability to move equipment and/or supplies weighing up to 33 pounds.
Ability to perform close precision work with hands.
Ability to remain in a stationary position (sitting/standing) for 50% of the time.
May require corrected vision to 20/20 or 20/25, and color vision depending on the role.

Qualifications

Education/Experience:

Required:
- Bachelor’s degree in Life Sciences, Engineering, or a relevant field from an accredited university.
- Minimum of 10 years of QA and/or related quality experience in manufacturing, utility, and/or packaging systems, preferably in the pharmaceutical or medical device field.
- Expertise in regulations and quality systems (e.g., product disposition, Deviations/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation).
- Demonstrated experience with risk assessments and vendor assessments.
- Experience with regulatory compliance and auditing practices, with certification preferred.
- Knowledge of GMP and experience reviewing GMP documents for compliance.
Preferred:
- Experience with LEAN, Six Sigma, or other continuous improvement methodologies.
- Expertise in core validation areas (sterilization, packaging, cleaning, utilities, etc.).
- Experience with statistical methods such as hypothesis testing, sampling, and CpK analysis.
- Competence in risk management and root-cause analysis tools and techniques.
- Experience in IT-related roles, including knowledge of PLC, SCADA, MES, and MS SQL, and audit experience related to IT systems.

Behavioral Requirements

Strong problem-solving skills, with the ability to identify the root cause of issues.
Excellent organizational and project management skills.
Strong written and verbal communication skills.
Ability to manage multiple core validation areas.

Commitment to Diversity & Inclusion

At Novo Nordisk, we are committed to being the best company for the world, and we believe this can only be achieved through diverse perspectives, backgrounds, and cultures. We are dedicated to creating an inclusive environment where all employees feel valued and empowered.

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 need assistance or accommodations to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

This structured job description provides a clear overview of the role’s responsibilities, qualifications, and company values, making it easy for potential applicants to understand what is required for the position.

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Quality Assurance Area Specialist Iv

Job Description

The Position

Relationships

Essential Functions

Physical Requirements

Qualifications

Behavioral Requirements

Commitment to Diversity & Inclusion

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