Production Clerk

Our 503B FDA-registered outsourcing facility located in Irving, TX is seeking diligent individuals to join our production team as Production Clerks. In this role, you will play a pivotal part in ensuring the smooth operation of our automated labeling system, aiding in product loading, retrieval, boxing, labeling, verification of counts, and depyrogenation of vials/caps. The position offers Monday - Friday shifts from 9 am to 6 pm, with occasional extra time as needed.

JOB DESCRIPTION

• Assist in the operation of the automated labeling system, including loading products, retrieving labeled products, boxing, stamping boxes with product information, and verifying counts.

• Ensure accurate documentation of work tasks on appropriate forms, such as Batch Production Records.

• Work efficiently in a clean room environment, adhering to Good Manufacturing Practices (GMP) documents including batch records, SOPs, and protocols.

• Maintain cleanliness, safety, and organization in the work area.

• Handle batch records and controlled documents to guarantee accuracy.

• Execute depyrogenation processes according to standard operating procedures (SOPs) to remove pyrogens from vials and caps.

• Adhere to strict protocols and guidelines while handling depyrogenation equipment and pharmaceutical products. Wear appropriate personal protective equipment (PPE) and follow established procedures to minimize the risk of contamination or injury.

• Maintain detailed records of depyrogenation processes, including equipment settings, process parameters, and quality control checks. Ensure documentation is accurate, complete, and compliant with regulatory requirements.

• Safely handle manufactured products and related documents for accuracy.

ESSENTIAL FUNCTIONS:

• Utilize mathematical skills to ensure proper product counts.

• Verify accuracy of labels and packaged products, documenting findings appropriately.

• Effectively communicate with team members.

• Follow document control processes accurately.

PERFORMANCE CRITERIA:

• Maintain professionalism and helpfulness in all interactions.

• Keep work area clean and organized.

• Demonstrate dedication to quality and compliance with SOPs.

• Adaptability to changing job tasks.

• Provide accurate, legible, and complete processing documentation.

• Ensure all work adheres to CGMP guidelines.

• Achieve 100% accuracy in labeling and packaging.

QUALIFICATIONS/EDUCATION:

• High school diploma or GED, or equivalent combination of education and experience.

• Proficiency in routine math calculations.

• Ability to read and interpret instructions accurately.

• Understanding of manufacturing processes.

• Excellent verbal and written communication skills.

• Capacity to work independently and collaboratively.

• Attention to detail.

ADDITIONAL RESPONSIBILITIES:

• Respond promptly to management inquiries, comments, and concerns.

• Maintain confidentiality of information and adhere to all policies, procedures, and compliance guidelines including HIPAA.

• Work autonomously with minimal direction, seeking consultation with leadership as necessary.