Production Lab Technician Duties and Responsibilities:

Set up equipment. Follow SOP's Operate general production equipment such as auto claves, pumps, scales, particle monitors, etc. Prepare solutions. Perform aseptic techniques and cGMP procedures. Document and maintain activity records according to cGMP regulations. Perform environmental monitoring during aseptic procedures. Collect samples. Perform daily cleaning of sanitation laboratories and equipment. Perform other duties as assigned. 

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Production Lab Technician Requirements and Qualifications: 

• High School Diploma or Equivalent Required.
• Post-High School education in a production or laboratory environment is preferred but not required.
• Experience in a production laboratory environment highly preferred.
• Excellent manual dexterity.
• Strong attention to detail and respect for quality assurance is required.
• Basic math skills
• Basic computer skills.
• Basic knowledge of Outlook, Word, and Excel.

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Advancement for a Production Lab Technician will be based on the following:

• Years of experience.
• Skill and education.
• Testing or continued education.
• Quality of work
• Personal growth within the Operations Department.

Job Overview:

Quality assurance specialists are responsible for monitoring, inspecting, and

proposing measures to correct or improve a company's final products and processes in order to meet established quality standards

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Quality Assurance Associate Duties and Responsibilities:

• Issue technical documents

• Organize, control, and oversee all GMP records and SOPs

• Implement and ensure adherence to Quality document change control

procedures

• Review and provide input for change requests require for GMP documents and routes documents for review approval

• Assess overall compliance with protocols, SOPs, company policies, applicable regulations, updates, and ensure appropriate approval of Quality documents

• Audit management and hosting

• Audit observations remediation and responses to FDA 483s and warning letters

• Product/Batch release approval as needed

• Implementation of GMP training program

• Continuous quality improvement activities

• Review and approve production records, calibration records,

validations/protocols (equipment, method, cleaning, software, process, stability), investigations, document change request, vendor qualification, and pest control records

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Qualifications

• Must be able to cope with varied levels of workload and multiple tasks

• Must be able to work in a fast paced and changing environment

• Accurate data entry skills

• Strong time management and organizational skills

• Excellent communication skills, both orally and in writing

• Willingness to be a team player and promote a positive team environment

• Excellent attention to detail

• Flexible and proactive to meet varied patient and company needs

• Self-motivated and able to work independently

• Strong interpersonal and people skills

• Must be able to work around hazardous and non-hazardous chemicals

• Analyze data and use this data to make appropriate decisions

• Ability to work in complex team environment and to collaborate with both external and internal professionals and other customers

• Computer skills – work processing, spreadsheets, and databases.

• Demonstrates creativity and flexibility

• Ability to operate in high-pressure situations

• Ability to provide effective feedback

• Ability to function independently and deal with multiple, simultaneous projects

• Ability to demonstrate a commitment to quality and excellence

Job Overview:

A quality control specialist is responsible for maintaining the quality of the products during production before storing for use and deliveries. Quality control specialists evaluate the products through internal specifications and processes.

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QC Specialist Duties and Responsibilities:

• Promote and enforce cGMP and SOP compliance in an FDA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety, and compliance with standards.

• Possess a working knowledge of cGMPs, FDA, and DEA regulations

• Evaluate product and raw material quality in a timely manner, according to defined specifications and test methods

• Perform quality inspection of filled goods and raw materials

• Produce inspection reports

• Verify QC Lab and stability samples for testing

• Review documentation (logbooks, receiving docs, production records)

• Maintain and inspect retains

• Perform and document in-process and finished good quality inspections of product and material

• Perform and document line clearance of production room cleans

• Verification of materials issued for manufacturing, and packaging

• Monitor, review, and document Cleanroom and drug cage climate

• Perform daily review of in-process compounding, vial inspection, and labeling

• Provide support to and coordinate with other departments to ensure product integrity

• Perform cleanroom inspections

• Document work performed in cleanrooms and warehouse

• Inspect and approve incoming products, equipment, and components:

    • API

    • Prepare new equipment for production (asset ID, determine   if calibration/validation is needed, paperwork to initiate use)

    • Batch components (verify components meet manufacturer’s specifications)

   • Consumables

   • Cleaning Supplies

   • PPE

• Inspect Manufacturing Processes – approve ingredients for daily batches and prepare

for daily inspection

  • Batch component preparation

  • Compounding (verify compounding is being performed per the batch record)

• Inspect Pre and Postproduction cleaning

• Inspect outgoing products

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Qualifications

• Must be able to cope with varied levels of workload and multiple tasks

• Must be able to work in a fast paced and changing environment

• Accurate data entry skills

• Strong time management and organizational skills

• Excellent communication skills, both orally and in writing

• Willingness to be a team player and promote a positive team environment

• Excellent attention to detail

• Flexible and proactive to meet varied patient and company needs

• Self-motivated and able to work independently

• Strong interpersonal and people skills

• Must be able to work around hazardous and non-hazardous chemicals

• Analyze data and use this data to make appropriate decisions

• Ability to work in complex team environment and to collaborate with both external and internal professionals and other customers

• Computer skills – work processing, spreadsheets, and databases.

• Demonstrates creativity and flexibility

• Ability to operate in high-pressure situations

• Ability to provide effective feedback

• Ability to function independently and deal with multiple, simultaneous projects

• Ability to demonstrate a commitment to quality and excellence