Operations Specialist

Swiss American CDMO•Carrollton, TX

7d•Onsite

About The Position

The Operations Specialist (OS) is responsible for being a subject matter expert with all batch records printed for Operations and ensuring that finished goods are reconciled and documented in an efficient, timely, and compliant manner meeting all FDA, GMP, ISO, OSHA, contract customer, and SAP policies. The OS will also assist the Scheduling Manager with planning packaging lines to fulfill customer orders.

Requirements

High School Diploma or equivalent preferred.
0-3 months of relevant experience in a manufacturing, production, or logistics environment is a plus.
Excellent written and verbal communication skills in English.
Strong mathematical skills, including addition, subtraction, multiplication, and division.
Ability to perform calculations related to raw materials and inventory.
Familiarity with units of measurement (weight, volume, distance).
Ability to follow detailed instructions and procedures accurately.
Strong attention to detail and organizational skills.
Ability to identify and resolve minor operational issues.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Basic computer skills, including file navigation and organization.

Responsibilities

Review all Manufacturing batch records for any corrections.
Communicates with Team Lead(s) to see which finished goods pallet(s) need to be reconciled.
Checks each batch ticket at the end of production for any specific details or special requirements needed in the BOM notes to reconcile materials or close out any finished goods pallets.
Ensures that Team Leads and Operators properly return raw materials used on a production line.
Communicates any improper documenting procedure(s) to Scheduling Manager when necessary.
Reconciles batch ticket raw materials using math formulas and functions.
Investigates material discrepancies
Able to use the Laserfiche program to review information on previous records.
Complies with all current good documenting practices and procedures, as well as meeting all FDA, GMP and internal quality policies.
Ensures inventory returns are completed, and transactions have been made.
Meets daily and monthly batch posting goals without needing constant supervision.
Works with QA/QC to ensure the release of finished goods in a timely manner
Represents Scheduling Department on interdepartmental project teams as required.
Provides input and insight into raw materials and batch records as requested.
Assist the Scheduling Manager with planning.
Ability to cover posting duties in Compounding, as needed.
Other duties may be assigned.