Quality Specialist

Job Title: Quality Specialist

PHARMA- CHEMICALS EXPERIENCE

ONSITE NJ-PHILLIPSBURG

CONTRACT: 18 /24  MONTHS

Open Role: Quality Specialist – NJ
Resumes: [email protected]
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.