QA Technician

Summary

This position is responsible for supporting the batch release department. Responsibilities of the department include review and release of all batch production records. Provide quality support and guidance to all manufacturing groups.

Essential Duties and Responsibilities

* Ensure timely QA review and release of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirements.

* Write, revise, and review SOPs.

* Perform QA on the floor activities (e.g. verifications, inspections, etc.)

* Ensure quality and consistency in documentation and adherence to SOPs.

* Participate in internal or external audits and support audit observations as needed.

* Ensure training requirements are met and records are up to date.

* Maintain and update departmental metrics and reporting.

* Work closely with the Manufacturing department to provide on-going Quality support.

* Represent QA at cross-functional meetings, providing QA input and decision making.

* Provide training to group and departments when needed

* Assist department supervisor/manager with work load/activity scheduling.

Qualifications (required)

* Must be very detailed oriented with a high quality of work

* Proficient in Microsoft Office applications (e.g. Word, Excel, etc)

Qualifications (preferred):

* Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)

* Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.

* Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.

* Application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

* Demonstrated attention to details and accuracy, required.

* General knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours, as needed.

Education and/or Experience

Minimum HS diploma

* Must have experience with computers and data and have achieved a comfort level with both universal applications (e.g., Microsoft Word, Excel, etc.) and job-specific applications (e.g., Manufacturing Execution Systems, Enterprise Resource Planning Systems, etc.)

Physical Demands

* Regular attendance is necessary to perform the essential functions of the job.

* Light work, frequent lifting up to 40 lbs.; frequent standing/walking.