Production Document Reviewer

Insight Global; Parsippany-Troy Hills (NJ); On-site; USD 52,000 - 68,000; Full time

Job summary

Insight Global is seeking a first shift Documentation Specialist to support a pharmaceutical manufacturing operation, ensuring production documents are completed accurately and in compliance with cGMP and quality standards. This role focuses on meticulous review of batch records, discrepancy identification, and robust document control.

Ideal candidates will have at least 3 years of experience in regulated GMP settings, exceptional attention to detail, and the ability to collaborate with

Qualifications

• High school diploma or equivalent.
• Minimum 3-year experience in the pharmaceutical/biopharma/biotech industry and within controlled environments.
• Ability to comprehend work instructions and SOPs.
• Exceptional attention to detail, accuracy, and documentation skills.
• Knowledge of cGMP and ability to follow gowning and hygiene protocols.
• Comfortable with wearing PPE such as gowns, gloves, and masks.

Responsibilities

• Review batch records for accuracy and completeness.
• Identify documentation discrepancies and resolve with cross-functional teams.
• Maintain document control processes and ensure compliance.
• Collaborate with cross-functional teams to support compliant manufacturing operations.

Skills

Document control

SOP reading

Attention to detail

GMP compliance

PPE compliance

Education

High school diploma or equivalent

Job description

Job Description

Insight Global is seeking a first shift (7:00am-3:15pm) Documentation Specialist to support a pharmaceutical manufacturing operation by ensuring production documentation is completed accurately, thoroughly, and in compliance with cGMP and quality standards. This individual will be responsible for reviewing batch records, identifying documentation discrepancies, maintaining document control processes, and collaborating with cross-functional teams to support compliant manufacturing operations. The ideal candidate is detail-oriented, organized, and experienced working in a regulated GMP environment.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• oHigh school diploma or equivalent
• oMinimum 3-year experience working in the pharmaceutical/biopharma/biotech industry and within controlled environments. Knowledge of manufacturing processes
• oAbility to comprehend work instructions and standard operating procedures (SOP's)
• oExceptional attention to detail, accuracy, and documentation skills.
• oKnowledge of cGMP and ability to follow gowning and hygiene protocols.
• oComfortable with wearing personal protective equipment (PPE) such as gowns, gloves, and masks. - additional technical or vocational education