Manufacturing Batch Record Coordinator

PDS Tech Commercial, Inc. • Morris Plains, NJ • 5h ago

Batch Record Coordinator - Pharmaceutical Manufacturing

$35.46 - $42.31/hour | Onsite in Morris Plains, NJ

About the Role

PDS Tech Commercial is seeking a meticulous and highly organized Batch Record Coordinator to support a leading pharmaceutical manufacturing operation in Morris Plains, NJ. This role is critical in ensuring the accuracy, compliance, and timely review of production documentation in alignment with cGMP standards, helping to deliver safe and effective products to patients.

Shift Options

Friday - Monday | 6:00 AM Start

Wednesday - Saturday | 6:00 AM Start (Please indicate your shift preference on your resume; final assignment will be based on business needs.)

Key Responsibilities

Oversee the full life cycle of issued labels and documentation, ensuring accuracy, completeness, and compliance with cGMP requirements.

Serve as a MES/SAP/LIMS Super User , providing system support, training, and troubleshooting for manufacturing teams.

Act as the primary point of contact for the Batch Record Process, including report creation, record approvals, and issue resolution.

Review all batch documentation for compliance with GDP and regulatory requirements, initiating deviations as needed and assisting with investigations.

TECO all manufacturing orders within MES.

Provide data and insights at manufacturing team meetings to identify trends and reduce documentation errors.

Manage the creation, issuance, reconciliation, filing, and archiving of batch records in accordance with CGTDM procedures.

Print and issue in-process labels, product labels, and related documentation to support operations.

Partner closely with Quality to address process issues and implement sustainable improvements.

Qualifications

Required:

Bachelor's degree or equivalent pharmaceutical manufacturing experience.

1-3 years of experience in a regulated cGMP environment.

Strong knowledge of Good Documentation Practices (GDP).

Excellent organizational, analytical, and communication skills.

Ability to work independently with minimal supervision.

Preferred:

Experience in aseptic manufacturing.

Proficiency with MES, SAP, and LIMS systems.

Why Join Us

PDS Tech Commercial is a Military Friendly® Employer that values precision, accountability, and teamwork. In this role, you will work in a collaborative environment where your contributions directly impact product quality and regulatory compliance. We offer competitive compensation, a commitment to employee development, and the opportunity to be part of a mission-driven organization producing life-changing therapies.

Apply Today

Bring your expertise in documentation control and compliance to a role where your attention to detail and problem-solving skills will make a meaningful difference. Submit your application and indicate your shift preference to be considered.

Pay Details: $35.46 to $42.31 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the @type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers

San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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