Lot Review Specialist

SCN BestCo

5d•$24 - $36

About The Position

As a member of the Quality Assurance team, the Lot Review Specialist performs a wide variety of activities to ensure compliance with applicable company and regulatory requirements. This position reviews and approves various types of regulatory documentation and provides support to the quality systems including lot review, investigations, and audit support.

Requirements

High school diploma or equivalent.
2 years’ experience in a quality or administrative role in a manufacturing environment.
Knowledge of dietary supplement manufacturing environment and Good Manufacturing Practices (GMP).
Proven ability to interpret and apply GMP regulations.
Proficiency with Microsoft Word, SharePoint, Excel, and Outlook.
Proven ability to perform and resolve investigations/deviations and root cause analysis.
Excellent attention to detail, written and verbal communication skills.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Must have the ability to communicate effectively, verbally and in writing, with internal staff and management.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Must be able to demonstrate practical problem solving and troubleshooting skills.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Nice To Haves

Associate degree in science or technical field.
HACCP certification.
Bilingual in English/Spanish.

Responsibilities

Review completed batch records for compliance and accuracy.
Perform final approval for release of finished product.
Support internal, customer, certification, and regulatory quality audits.
Support the training of all employees through lot review and critical process steps within the batch production records.
Respond in real time to operational issues to prevent and avoid deviations, including immediate response to questions from operations personnel that could potentially lead to non-conformances and failures.
Facilitate resolution of potential nonconformance events and complete deviation investigations as required.
Ensure operational compliance by making sure policies and procedures are followed.
Identify and report redundant, difficult, or outdated Batch Production Forms to management.
Coordinate storage, filing and retrieval of batch records.
Provide input and assist with implementation of improvements to streamline the BPR review and approval process.
Provide training in Good Manufacturing Practices (GMP) to new and existing employees as directed.