Quality Specialist
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Job Location:
Phillipsburg, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Quality Specialist
PHARMA- CHEMICALS EXPERIENCE
ONSITE NJ-PHILLIPSBURG
CONTRACT: 18 /24 MONTHS
Open Role: Quality Specialist NJ
Resumes:
Please note:
For this role our client cannot provide visa sponsorship and also cannot accept Corp-to-Corp arrangements. Candidates must already have independent work authorization in the U.S. (W2 without sponsorship).
Job Description:
We are seeking an experienced Quality Assurance professional to lead the continual improvement coordination and monitoring of the Quality Management System (QMS). This role is highly hands-on supporting compliance initiatives and operational excellence with a strong focus on CAPA GMP and process improvement. The successful candidate will also play a key role in digitizing batch records and training staff on updated procedures.
Key Responsibilities:
Establish coordinate and continually improve the Quality Management System (QMS).
Lead CAPA initiation investigations and follow-up to ensure timely and compliant resolution.
Manage the digitization of batch records project ensuring accuracy and compliance.
Review and update procedures SOPs and work instructions to align with GMP standards.
Handle customer complaints event investigations SCARs and nonconformances.
Deliver hands-on training on quality processes and compliance requirements.
Participate in audits quality meetings and Corrective Action Team activities.
Prepare audit paperwork trending reports and compliance documentation.
Perform QA/QC evaluations statistical data analysis and recommend improvements.
Partner with manufacturing and cross-functional teams to ensure product quality and compliance.
Support process validation and maintain QC objectives in line with company goals.
Build and maintain strong relationships with associates clients and suppliers.
Required Skills & Experience:
Minimum 5 years of quality assurance experience in a GMP-regulated environment.
Proven experience with CAPA initiation complaint handling and event investigations.
Background in manufacturing operations with strong understanding of batch record processes.
Hands-on experience with SOP development and updates under GMP guidelines.
Skilled in training staff and ensuring compliance with procedures.
Proficiency in statistical analysis tools and database management.
Strong organizational analytical and communication skills.
Desired Skills:
Experience in pharmaceutical biotech CDMO or medical device industries.
Familiarity with regulatory requirements (FDA EMA ISO 13485 etc.).
Experience leading digital transformation projects (e.g. batch record systems).
Audit preparation and execution experience.
Education Requirements:
Bachelors degree in Quality Assurance Engineering Life Sciences or related field.
Advanced degree or professional certification (e.g. ASQ Six Sigma) preferred.
Required Experience:
Unclear Seniority
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.
