6102 - FS QC - DRWS - Sr. Document Reviewer

Inteplast Group•Miramar, FL

About The Position

Under the supervision of the Quality Control Assurance Manager conduct final audit of Batch Manufacturing Records (BMRs) and Packaging Records (PPRs). Refer to related SOPs and checklists to make sure 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 Assurance, in compliance with cGMP’s, SOP’s Federal and State Regulations, and Food Safety regulations.

Requirements

BS/BA in life sciences or other closely related discipline or HS Diploma and four minimum years of related experience.
Minimum of four years of practical document control experience in a nutraceutical or pharmaceutical environment or working knowledge of nutraceutical/pharmaceutical process.
Working knowledge of pharmaceutical/nutraceutical documentation processes and techniques, including but no limited to good working knowledge of PC software and Word processing in a business environment, good knowledge of math, excellent grammar/English/proof reading skills, good written and oral communication skills, high degree of organizational skills and attention to detail.
Intermediate Microsoft Excel skills (data entry, filtering, basic formulas).
Strong organizational, communication, and problem-solving skills.
Ability to multitask while maintaining a high level of accuracy and attention to detail.
Ability to work efficiently and effectively in a fast-paced manufacturing environment.
Capable of effectively managing job-related stress and fostering productive workplace interactions.
Ensure consistent, dependable attendance and demonstrate flexibility to accommodate non-standard work hours as necessary.

Responsibilities

Review executed batch records according to production schedules, Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP's).
Assist with master records creation and approval.
Maintain quality systems documentation, change control, investigation, deviations and procedures, and related records per established processes, procedures and standards.
Issue and track controlled documents per 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 are 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 present 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, responsible for ensuring the execution of corrective actions, and for ongoing compliance with the Internal Audit program.
Responsible to comply with all our food safety and food quality programs, procedures, and policies or its references. Member of the HACCP team, if required.