Manufacturing Quality Technician

POSITION DESCRIPTION:

Perform a variety of technical quality duties in the areas of Incoming Quality Assurance, Production, Secondary Packaging Operation, and general Quality Systems duties using appropriate industry standard practices, company procedures and regulatory policies as required. Has some working knowledge of quality terms and definitions as well as investigative and data analysis tools. Works under limited supervision, but can follow general instructions for day-to-day activities and minor projects. Has the desire and ability to learn about and implement quality processes and improvement methodologies. Experience in medical device or other regulated industry.

POSITION RESPONSIBILITIES:
Provide support to Mfg Quality Engineers for:
•Reviewing manufacturing device historic records for conformity to procedures and good manufacturing practices and release upon acceptance.
•Resolving production/process problems to achieve production and product availability goals on schedule on the drug kitting line.
•Acting as a liaison between the manufacturing and quality teams. Communicates pertinent information to the teams on a regular basis.
•Participates in ensuring deviations and non-conformances are reconcile before releasing the product.
•Suggests documented procedure improvements and communicates with engineering on the implementation of change.
•Participates with production to disposition non-conforming components and perform inspection activities.
•Performs periodic self-assessments or other audit readiness activities of production operations and Quality Assurance
•Support of production; this includes the use of manufacturing execution systems.
•Documents applicable data on quality and manfacturing forms and processes.
•Performs other related Mfg quality duties as required or assigned by the supervisor.
•Attend meetings as required by manager.
•Required to spend extended periods of time on computer-based work.

DESIRED/PREFERRED QUALIFICATIONS:

•Two years (2) experience with Pharmaceutical or Medical Devices production line.
•Proficient in MS-Office applications and FACTORY works.
•Good communication, interpersonal and technical writing skills.
•Able to work as a team member and support multiple projects and responsibilities.
•Working knowledge and ability to apply good inspection techniques with minimum supervision.
•Available for shift work when necessary
•Knowledge of 21 CFR 820, and 21 CFR 210/211.