Quality Control Technician

Description:

Essential Duties and Responsibilities:

Conduct product testing, including testing to support complaint investigations and stability verification

Generate product testing results reports

Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records.

Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.

Conduct spot-check inspections/audits of production operations

Participate in the internal audit program

Write, review and approve Standard Operating Procedures (SOPs) as necessary

May assist in supporting the Document Control program, record retention areas, and sample retention areas

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)

Education and/or Experience:

Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.