Document Reviewer

Florida Supplement

Mon - Fri

8:00 AM - 4:45 PM

TITLE:Document Reviewer B

POSITION OBJECTIVE: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

QUALIFICATIONS:

• 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.

JOB 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.

MACHINES, TOOLS, EQUIPMENT, ELECTRONIC DEVICES & SOFTWARE:

• Proficient with MS Office Suit (Word, Excel, PowerPoint & Outlook)

Other:

• Working knowledge of Safety in the Workplace Rules and Regulations.
• Working knowledge of cGMPS's and SOP's.

Florida Supplement is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

• 10301 Commerce Pkwy, Miramar, FL 33025, USA