Safecor Health, LLC
  • 28-Aug-2017 to 30-Nov-2017 (EST)
  • Quality Assurance
  • Woburn, MA, USA
  • Full Time

Medical, Dental, Vision, Short Term Disability, Life Insurance, Paid Time Off (PTO), Earned Sick Time (EST), Holiday Pay, 401k


RESPONSIBILITIES

Perform batch record reviews, in process final release audits and disposition of final product to assure procedural adherence to the repackaging operations while working in a clean room environment predominately.

Perform tasks in the preparation for and conducting of internal and external audits as required.

Maintain quality assurance procedures and activities required to ensure that the company's processes and products are in compliance with applicable quality standards and requirements.

Maintain FDA complaint Quality Systems (21 CFR, parts 210, 211, 820, 11 and 4).

Maintain the processes needed for Quality System to function effectively.

Support actions related to all observations and comments resulting from an inspection or request by the customer. Support actions for changes in a timely fashion as committed to the Inspection Group (FDA, OSHA) or customer.

Support systems related to Training (SOPs, forms), Change control, records requirements, facilities requirements, incoming inspection, receiving, storage and segregation of all components drug material and retain samples, equipment controls and validations, process controls, labeling control, complaints, recalls and gamma radiation and sterilized finished product.

Support preparation of or prepare any change orders, deviations, incident reports and CAPAs.

EXPERIENCE

Experience in medical device packaging environment preferred.

Experience with performing inspections and the use of metrology equipment.

Experience and understanding of regulatory requirements (FDA, Medical Device) and development and implementation of Quality Systems.

Understanding of sterilization process validation a plus.

Effective problem solving skills

Extremely well organized and prioritizing skills

Excellent verbal and written communication skills.

Self-motivated, ability to work in a team environment and achieve individual and company success

Microsoft Word, ERP and Excel experience is a plus.

High School Degree required; college coursework preferred

Safecor Health, LLC
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