Qms Specialist

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Hello,

Greetings from R. L. Klein & Associates.

Job Role: QMS Specialist

Location: New Jersey (On-site)

Duration- Full-Time

JOB DESCRIPTION:

We are seeking an experienced QMS (Quality Management System) Specialist to support and enhance the quality systems within our biologics operations. The ideal candidate will have strong expertise in managing deviations, change controls, and CAPA, along with a solid background in biotech or pharma environments.

Key Responsibilities

Manage and execute Deviation investigations with timely closure and root cause analysis.

Lead and maintain Change Control processes adhering to internal and regulatory requirements.

Drive Corrective and Preventive Actions (CAPA) from initiation to effectiveness checks.

Ensure compliance with cGMP, FDA, and other regulatory guidelines for biologics manufacturing.

Support internal and external audits, prepare documentation, and ensure QMS readiness.

Collaborate with cross-functional teams including QA, QC, Manufacturing, and RA.

Maintain and update QMS documentation, SOPs, and quality records.

Continuously identify process improvement opportunities to strengthen the QMS.

Required Qualifications

Bachelor’s or Master’s degree in Biotechnology, Pharmaceutical Sciences, Biochemistry, or related field.

Minimum 4–5 years of experience working in the biologics / biopharmaceutical industry.

Hands-on expertise in Deviations, Change Controls, and CAPA management.

Strong knowledge of cGMP, ICH guidelines, and FDA regulations.

Excellent analytical, documentation, and communication skills.

Preferred Certifications

(Any of the following or similar)

Six Sigma Green Belt

Certified Quality Auditor (CQA)

Certified Quality Improvement Associate (CQIA)

QMS Lead Auditor certification (ISO 9001 or ISO 13485)

Additional Requirements

Ability to work on-site in New Jersey.

Strong attention to detail and problem-solving mindset.

Ability to work effectively in a fast-paced, regulated environment.

Pay: $29.85 - $35.95 per hour

Expected hours: 40 per week

Work Location: In person