USA Documentation Specialist I Manufacturing Quality 1st Shift

Adecco Healthcare & Life Sciences

Batch Record Reviewer / Quality Documentation Specialist

Fully Onsite | 1st Shift | Temp Role (Potential Extension)

Position Summary

The Batch Record Reviewer is responsible for ensuring manufacturing batch records comply with regulatory requirements and internal quality standards. This role focuses on reviewing documentation for accuracy, identifying errors, ensuring GDP compliance, and supporting continuous improvement within a GMP-regulated manufacturing environment.

The position works closely with Manufacturing Technicians and Quality teams to ensure timely correction of documentation errors and to maintain high standards of data integrity, compliance, and operational efficiency.

Key Responsibilities

Batch Record Review & Documentation Control

• Review manufacturing batch records for completeness, accuracy, and compliance with regulatory requirements

• Ensure adherence to Good Documentation Practices (GDP) across all records and documentation workflows

• Track and ensure timely correction of identified errors in collaboration with Manufacturing Technicians

• Maintain documentation accuracy and ensure batch record review cycle times are met

Quality Systems & Compliance Support

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

• Participate in deviation investigations and CAPA (Corrective and Preventive Action) processes as needed

• Maintain error tracking metrics and analyze recurring documentation issues to support continuous improvement

• Support compliance with GMP and internal quality system requirements

Manufacturing Collaboration & Training Support

• Collaborate closely with Manufacturing Technicians to resolve documentation discrepancies

• Provide guidance and coaching on GDP compliance and documentation best practices as applicable

• Communicate effectively with cross-functional teams to ensure alignment on quality expectations and corrections

• Support simplification of batch record structures to reduce documentation errors where applicable

Required Qualifications

• High School Diploma with 5+ years of relevant experience, OR

• Associate Degree with 3+ years of experience, OR

• Bachelor's Degree with 1+ year of relevant experience (including final-year candidates)

• Experience in pharmaceutical, biotechnology, or regulated manufacturing environment required

• Strong understanding of GMP, GDP, and documentation control principles

• Experience with CAPA, deviations, and quality systems

• Familiarity with technical documentation systems or ERP platforms

• Strong attention to detail with ability to identify errors quickly and accurately

• Excellent communication and interpersonal skills for cross-functional collaboration

Preferred Qualifications

• Experience in manufacturing or GMP production environments

• Exposure to GDP compliance programs and documentation improvement initiatives

• Experience working with deviation investigations and CAPA systems

Core Competencies

• High attention to detail and documentation accuracy

• Strong compliance mindset and quality focus

• Ability to identify, escalate, and resolve documentation issues efficiently

• Strong analytical and error-tracking capabilities

• Effective communication and teamwork in a manufacturing environment

• Ability to work in a fast-paced, regulated setting

• Continuous improvement mindset

Work Environment

• Fully onsite role (free parking provided)

• Business casual dress code

• 1st shift: Monday-Friday, 7:30 AM - 4:00 PM

• Temp assignment with potential for extension

• High interaction with manufacturing floor and quality systems

Compensation

• Up to $35.46/hr (depending on experience and qualification alignment)

Pay Details: $30.00 to $34.00 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

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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.