Quality Technician: Biopharmaceutical Products Cleanroom

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       Full time

 

What You Will Achieve

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You will be part of a team of efficient and dynamic technicians assigned to manufacture biopharmaceutical products within a state-of-the-art facility. You will be responsible for operating inspection equipment, completion of support tasks and at times the oversight of assigned activities, in order to obtain the production plan of record. You will assist in process support and continuous improvement activities. You will be proactive in taking up trainings, documentation and technical completion of work as required in a regulated cGMP environment

As part of the Quality team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

 

How You Will Achieve It

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• Manage own time, professional development, and be accountable for own results.

• Prioritize own workflow and may assist in prioritizing the workflow of less-experienced colleagues.

• Ensure quality standards and best practices are followed throughout the manufacturing process.

• Maintain proper documentation, such as training records, batch records, Quality Inspection Reports, and Certificates of Conformance.

• Operate, service, make adjustments, clean and sterilize one or more of a variety of production related equipment in compliance with equipment, product and process cGMP's and safety/security regulations.

• Assure that equipment is operating properly, reports and/or corrects malfunctions and may assist others in complex set up/repair operations.

• Complete work instructions and maintains cleanroom environment to comply with regulatory requirements.

• Provide support during audits and with audit observation closure.

• Employ Automated systems, ERP systems named IQMS, and available technology to execute work.

• Maintain cross-functional communication with technology transfer teams, manufacturing, supply chain, quality and engineering as necessary.

 

ROLE SUMMARY

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The Quality Technician will be on a team of a Quality Engineer and a technician, assigned to manufacture biopharmaceuticals within a state-of-the-art facility. The Quality Technician will be responsible for operating equipment, completion of support tasks and at times the oversight of assigned activities, in order to obtain the production plan of record. Manufacturing functional areas include: Injection Molding and Assembly. The Quality Technician will be accountable for the required training, documentation and technical completion of work as required in a regulated cGMP environment.

 

ROLE RESPONSIBILITIES

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Following SOP’s, procedures and utilize equipment and complete assigned tasks in a cGMP environment. The Quality Technician will be responsible for general cleanroom housekeeping, stocking and cleanliness of the cGMP facility. This position will participate in continuous improvement initiatives when opportunity arises. This position reports to management any potential or actual deviations from regulatory requirements.

 

PREFERRED QUALIFICATIONS

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• Experience working in a cGMP environment

• AA or AS in Math Biology or Science, or BA/BS preferred.

 

Email tonya.foster@coretechnologycorp.com for more information or to apply.