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Documentation Specialist I- Manufacturing/Quality

Adecco US, Inc. • Pearl River, NY • 2h ago

Quality Assurance Specialist - Batch Record Review

Pay Rate: $ 35.46/hour

Shift: 1st Shift

Location: Fully Onsite

Position Overview

Adecco Healthcare & Life Sciences is hiring a Quality Assurance Specialist for our pharmaceutical partner. This position is responsible for reviewing manufacturing batch records, supporting GDP compliance initiatives, and assisting with quality systems activities within a regulated pharmaceutical or biotechnology environment.

The ideal candidate will have experience with CAPA, batch record review, technical writing, documentation systems, ERP systems, and quality investigations while maintaining a strong attention to detail in a fast-paced manufacturing setting.

Key Responsibilities

Track and review manufacturing batch records to ensure compliance with regulatory and GDP requirements

Follow up with Manufacturing Technicians to ensure documentation corrections are completed accurately and in a timely manner

Maintain error tracking metrics and support initiatives to reduce recurring GDP violations

Coach and support shop floor personnel on Good Documentation Practices (GDP) requirements

Identify and escalate documentation and GDP issues that may impact product safety, efficacy, or quality

Review batch record structures and recommend process improvements to minimize documentation errors

Ensure timely batch record review cycle completion

Participate in deviation investigations and support CAPA creation and follow-up activities

Utilize documentation and ERP systems to review records, identify discrepancies, and implement corrective actions

Prepare and maintain technical documentation and quality records with a high degree of accuracy

Collaborate cross-functionally within manufacturing and quality teams in a regulated environment

Required Qualifications

High School Diploma with 5+ years of relevant experience OR

Associate Degree with 3+ years of relevant experience OR

Bachelor's Degree with 1+ year of relevant experience

Required Experience & Skills

Experience with CAPA, batch record review, and technical writing

Strong knowledge of quality systems and documentation practices

Experience using documentation systems and ERP systems

Ability to identify documentation errors and implement corrective actions

Experience within pharmaceutical or biotechnology manufacturing environments

Strong organizational skills and attention to detail

Ability to work efficiently while maintaining a high degree of accuracy

Strong interpersonal, communication, and teamwork skills

Preferred Qualifications

Manufacturing GDP experience

Deviation investigation experience

Experience supporting regulated manufacturing operations

Pay Details: $35.46 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

Military connected talent encouraged to apply

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

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