Document Reviewer

Inteplast Group • Miramar, FL

1d • Onsite

About The Position

Under supervision, conducts final audit of Batch Manufacturing Records (BMRs) and Packaging Records (PPRs). Referencing SOPs and checklists, assures that the records comply with company regulations and cGMPs. Responsible for maintaining complete and accurate records and for performing document control functions associated with Quality Control and Assurance, in compliance with cGMP's, SOP's, Federal and State Regulations, and Import/Export regulations.

Requirements

• Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary.
• Capable of effectively managing job-related stress and fostering productive workplace interactions.
• Good knowledge of math skills, excellent grammar/English/proof reading skills, good written and oral communication skills, high degree of organizational skills and attention to detail.
• BS/BA in life sciences or other closely related discipline or HS Diploma and 2 years related experience.
• Requires 2-4 years of practical document control experience in a nutraceutical or pharmaceutical environment or working knowledge of nutraceutical/pharmaceutical process.
• Working knowledge of Safety in the Workplace Rules and Regulations.
• Working knowledge of cGMPS’s and SOP’s.

Responsibilities

• Review executed batch records according to production schedules, Standard Operating (SOPs) and current Good Manufacturing Practices (cGMP’s).
• Assist with the master records creation and approval.
• Maintain quality systems documentation, change control, investigation, deviations and procedures, and related records according to established processes, procedures and standards.
• Issue and track controlled documents according to established Company procedures and systems.
• Coordinate and ensure timely and accurate document flow process, including initiating routing process, revision and approval.
• Ensure all documented records and documentation is compliant with established rules, regulations, protocol, cGMP's and all other applicable standards.
• Keep trending analysis for the error encounter during the batch record review and presented to the affected departments.
• Perform data retrieval, data analysis and reporting via use of information management systems and or quality management systems to report to head of department.
• Assist or perform internal audits activities, being responsible for ensuring the execution of corrective actions and ongoing compliance with the Internal Audit Program.
• Responsible to comply with all our food safety and food quality programs, procedures, and polices or its references.
• Ensure that all personnel in the company apply and meet with the established controls and follow all requirements applicable to the members of the food safety team.
• Will be required to perform other duties as requested, directed or assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree