Basic Job Functions:
Assigns, prints, and reviews all documents associated with batch production, has errors corrected, and reports findings to appropriate departments. This activity includes adherence to Accupac, Inc.s Standard Operating Procedures, the FDAs Good Manufacturing Practice Guidelines and the customers written procedures.
Essential Functions of the Job:
Demonstrate and assure compliance with established Accupac, Inc. Standard Operating Procedures, the FDAs Good Manufacturing Practices guidelines and the customers written procedures.
Assign batch codes to all Bjobs
Print and issue all upcoming BMOs and ancillary paperwork (weight sheets, tank measurement sheets, special instructions, etc.) for future batches, as per schedule.
Coordinate with various department heads on which jobs are validation, qualification, or customer batches.
Main function is to audit completed batch records for compliance and proper documentation procedures. Includes:
o Checking bulk ticketing vs recorded yield for agreement
o Quarantine ticket vs batch start date
o Raw material tickets are consumed to the batch, and total within 1% of required amount
o Assure all data fields of the BMO are completed, legible, and correct
Track number of batches reviewed, and number of paperwork errors per employee. Report monthly.
Get batch record corrections, missing signatures, etc. from manufacturing personnel.
Instruct compounders regarding errors, in order to prevent repetition.
Sign finalized BMOs as releasable and send to QA department.
Issue and review maintenance and use logbooks for each piece of manufacturing equipment
Assist in troubleshooting and solving departmental problems or obtain the necessary help to solve the problem.
Communicate effectively with both management and hourly employees.
Make, Issue and Review Logbooks as needed.
Every week: print, assemble, log and file batches for the next week.
Log any subtractions from the schedule and keep for future use.
Assist with any special projects.
All other duties as assigned.
Minimum Requirements of the Job:
Able to read, write, speak and understand the English language fluently.
Possess excellent reading comprehension skills.
Able to prepare reports, training records, and manuals.
Able to perform basic math functions (addition, subtraction, multiplication, division and percentages) with both whole numbers and fractions.
Possess a working knowledge of the metric system.
Able to perform tasks without constant supervision.
Possess the training associated with the position of Chemweigh Technician and/or Compounder
Physical Requirements:
Walking/Standing on concrete floors for up to two (1) hour per day and walking long distances.
Sitting for 80-90% of the work day.
Climbing step stools and maintaining balance.
Lift/Carry items up to 25 pounds.
Pushing/Pulling items up to 50 pounds.
Supervisory Responsibilities: No
Travel: None
Education and/or Experience: Must have a high school diploma or GED. Must have 2-5 years of experience in a GMP environment.
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