Quality Specialist

Job Description

Job Description

Job Title : Quality Specialist

PHARMA- CHEMICALS EXPERIENCE

ONSITE NJ-PHILLIPSBURG

CONTRACT : 18 / 24 MONTHS

Open Role : Quality Specialist – NJ

Resumes : lpolo@jacobsmgt.com

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 :

Bachelor's degree in Quality Assurance, Engineering, Life Sciences, or related field.

Advanced degree or professional certification (e.g., ASQ, Six Sigma) preferred.