1(904)362-3629 [email protected]

Quality Technician, Arcadia

Position Overview:

The Quality Technician monitors adherence to policies and procedures to ensure that quality standards are met during production. They are responsible for maintaining protocols to ensure compliance to the cGMP aspects of manufacturing operations including handling, storage, and manufacturing of all activities involved in the production of pharmaceutical grade medical marijuana products. They should understand and be capable of administering a MBR (Master Batch Record) program for technical operations (Extraction/Formulation/Filling). They are responsible for the testing of the extraction and formulation batches and the assurance of purity and purported potency of the commercial products. In addition, they provide regular feedback to the Quality Manager and other team members to ensure full understanding and compliance with defined protocols.

 

Major Areas of Responsibility include:

·         Proper monitoring of manufacturing processes and packaging of products.

·         Provide constructive input on the processes regularly to Quality Manager and other team members as appropriate.

·         Maintain the quality management system including Corrective and Preventive Action (CAPA) procedure and collect and analyze information, identify and investigate product and quality problems or defects, and take appropriate and effective corrective actions.

·         Disassemble and reassemble machinery.

·         Maintain material traceability, and suspect material quarantine procedures. Pull samples.

·         Validate internal laboratory process before external use. Maintain internal and external Quality Agreements.

·         Control and track controlled substances and report to proper agencies.

·         Read laboratory documentation and communicate with external laboratories.

·         Implement failure investigation procedures. Control for preventing distribution of nonconforming product. Track errors observed to establish patterns with processes or personnel. Problem solve issues as they arise.

 

Minimum Qualifications (Skills, Knowledge & Abilities):

·         2 years’ experience working in a quality function; preferably in pharmaceutical or food/beverage production manufacturing

·         Knowledgeable in current Good Manufacturing Practices (cGMPs) to include the application of Code of Federal Regulations

·         Knowledgeable in Change-Control procedures and processes

·         Knowledgeable in Microsoft Suite with ability to maintain documents, prepare spreadsheets, perform analytics including charts and graphs, and craft presentations

·         Ability to multi-task, problem-solve and respond with a sense of urgency in a fast-paced environment and make effective and timely decisions with confidence

·         Ability to communicate effectively, both oral and written, and build and maintain collaborative working relationships with internal and external stakeholders

·         Preferred experiences include:

·         Experience testing extraction and formulation batches to assure purity and purported potency of commercial products

·         Knowledgeable in administering a Master Batch Record (MBR) program for technical operations to include extraction, formulation, filling and packaging

·         Knowledgeable in Cleaning Validation (CV) program methods and the CAPA process (to include deviations and corrective action)

·         Knowledgeable in High-Performance Liquid Chromatography (HPLC) or similar wet-chemistry testing method for testing and analyzing components

Travel %: minimal

FLSA status: Non-Exempt

Additional Abilities Required:

·         The job requires physical activity, including prolonged standing, repetitive bending, climbing, and lifting or moving up to 10 pounds (or more with a coworker). Good visual acuity, hand-eye coordination, manual dexterity, and ability to perform repetitive motions with accuracy is required. The noise level in the work environment is usually moderate.

 

Apply directly: https://col-care.com/jobs/#op-342685-quality-technician

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