What are the responsibilities and job description for the Operations Specialist position at Swiss American CDMO?
Position Summary: 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.
Essential Duties and 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.
Essential Skills and Qualifications:
- 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.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate. Overtime may be required to meet monthly batch posting goals
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The employee must frequently lift and/or move up to 25 pounds. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to sit. The employee is occasionally required to stand and walk.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor