Associate Ii, Compliance - Qa

5+ years

Not Disclosed

New Brunswick

18 June 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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: Associate II, Compliance - QA

Location: New Brunswick, New Jersey
Employment Type: Direct Hire
Pay Rate: Dependent on Experience (DoE)

Job Summary:

The Associate II, Compliance - QA is responsible for ensuring site compliance with cGMP regulations and internal quality procedures. This role involves managing investigations, product quality complaints, CAPAs, deviations, and change controls. The Associate II, Compliance also provides assistance during regulatory, corporate, and internal audits.

Key Responsibilities:

Investigations and Complaints:
- Conduct investigations of site incidents/deviations and product quality complaints in the Trackwise system.
- Provide final reviews of investigations.
Deviation Management:
- Execute a robust deviation management program.
- Ensure effective root cause analysis and corrective/preventative actions.
Change Controls and CAPA:
- Review and approve change controls, CAPA, and Global CAPA.
- Monitor the effectiveness of CAPA.
Quality Metrics Management:
- Collect and report quality metrics.
- Trend site incidents, product quality complaints, change controls, out-of-specifications, out-of-trends, and CAPA monthly, quarterly, and annually.
Regulatory Readiness:
- Assist in ensuring FDA readiness for the facility.
- Provide support for regulatory audits, internal/external inspections, and other audits.
- Follow up on operational findings from FDA and other regulatory bodies.
Mock Inspections:
- Participate in and conduct mock inspections.
- Assess gaps in the system and review documents for compliance with current regulations and cGMPs.
Compliance Improvement:
- Identify compliance issues and support the implementation of changes for constant improvements.
- Ensure procedures reflect current practice.
- Create and revise SOPs as applicable.
Protocol and Report Reviews:
- Review and approve qualification protocols and reports for equipment and product validations/verifications.

Requirements:

Education: Minimum Bachelor's degree.
Experience: At least five years in the pharmaceutical industry in a quality function role.
Skills and Knowledge:
- Experience in an international, multicultural matrix organization.
- Knowledge of QMS and driving investigations to completion.
- Thorough understanding of GMPs.
- Proficiency in MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS.
- Strong knowledge of project management principles, practices, techniques, and tools.
- Excellent interpersonal and communication skills, both written and verbal.
- Excellent organizational and time management skills; ability to prioritize and manage multiple assignments.
- Self-starter with a hands-on approach and a can-do attitude.
- English language proficiency at Intermediate-B1+ (comparable to Global CEFR Independent B1) level.

Benefits:

Our client offers a competitive compensation package and an excellent benefits package for eligible candidates.

About ProStaff Solutions Inc:

ProStaff Solutions is committed to all aspects of staffing services, offering comprehensive best practices for our clients and employees.

Vision:

To be the premier employment solutions provider to every community we serve.

Mission:

To bring the right people to the right job every time, improving people's lives and increasing our customers' and employees' success.

Values:

Integrity: Our success depends on personal integrity and honesty. We reward hard work and believe in open communication.
Community Leadership: Strengthening our communities through leadership and donations of time and resources.

How to Apply:

Please visit ProStaff Solutions to explore all opportunities.

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Associate Ii, Compliance - Qa

Job Description

Job Title: Associate II, Compliance - QA

Job Summary:

Key Responsibilities:

Requirements:

Benefits:

About ProStaff Solutions Inc:

Vision:

Mission:

Values:

How to Apply:

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