Quality Systems Specialist - Quality Assurance II - Full-time / Part-time

The Quality Systems Specialist is responsible for tracking and trending of cGMP and compliance activities, including Annual Product Reviews (APRs), monthly, quarterly, and annual trending reports, and trending support of deviations, investigations and CAPA effectiveness.

Duties /Responsibilities

• Performs Annual Product Reviews for all commercial products
• Tracks and trends miscellaneous cGMP Data for Production, QA, QC, Validation, etc.
• Conducts monthly, quarterly, and annual trending reports
• Trains new employees on tracking and trending compliance and reviews training documentation for accuracy
• Utilize electronic training system to facilitate compliance to training program of site personnel
• Applies principles outlined in CFR, ICH, and FDA guidelines
• Assist with FDA inspections as necessary and/or required
• Follows requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into processes
• Coordinates with other departments about recent trends and reporting
• Direction Received: Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
• Analytical Requirements: Assignments require almost continual analysis of figures, data trends, and results of all kinds which directly affect the policy of the company.
• Decisions and Judgment: Provides consultation or expert advice to management on operational issues
• Initiative: Independent action within an established field is required; new procedures and new approaches to problems must be assigned

Minimum Qualifications

• Bachelor's Degree in Pharmacology, Pharmaceutics, Science or related field with 2-4 years' experience in pharmaceutical or biotech industry or equivalent combination of education and experience required. Master's degree preferred.
• Qualified candidates must be willing to submit to a standard drug screen and background check.
• All candidates must be flexible working between the hours of 7am - 5pm Monday through Friday for training. Flexbile working overtime and some weekends if necessary.

Starting Pay, Duration and Benefits:

• $19-20/hour starting. Based on experience and skill level.
• 6 month contract to hire position. Only looking for individuals looking for a long term career opportunity. This is not a short term position at all.
• Full Benefits available (Medical, Dental, Vision, 401K, etc.)

If interested, please contact Saiday with Aerotek actively working on the 2 immediate openings. This position is time sensative, please contact 913-905-2731 along with emailing your resume to smulbah(at)aerotek.com as soon as possible.

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.