** Senior Quality Associate **

Senior Associate (Corporate Quality Compliance) Located in Marlborough, MASummary: Supports the routine monitoring, intake, assessment, follow up, sample return, response letter preparation and distribution, complaint reports, file and electronic system maintenance of adverse events and technical product complaints.Duties: Performs duties within the Corporate Quality Compliance department to assure that the company and its suppliers achieve and maintain compliance with GMP requirements, so as to help assure commercial sales and successful NDA reviews.(1) Review intake information from customer calls to monitor for technical product complaints; (2) Enter technical product complaint cases into the validated complaint database; (3) Review adverse event intake information to monitor for adverse event product complaints and technical product complaints; (4) Categorize the complaints and determine the need for investigation; (5) Coordinate requests and replies to customers for follow-up information on product complaints; (6) Obtain follow-up complaint information via telephone interviews with consumers, pharmacists, and other health care professionals and enter this information into the database; (7) Alert management of issues requiring follow-up; (8) Coordinate the quality investigation of the product complaint; (9) Send out medication return kits to obtain medication for potential complaint investigations; (10) Track the shipment of the medication return kits in the complaint database; (11) Determine the appropriate response to send to customer for technical product complaints; (12) Intake follow-up information related to the complaint and the investigation into the complaint database; (13) Generate final complaint reports, including a conclusion which assesses whether or not drug product failure occurred; (14) Manage the product complaint files; (15) Assist manager in preparing product complaint data for audits and product complaint review committee assessment.Education: -Minimum of Associate's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or equivalent combination of training and experience in a regulated industry. Experience: -Minimum of 2 year's experience in an FDA-regulated biotechnology, pharmaceutical or medical device company. -Experience preferred with handling product complaints, obtaining follow-up information through telephone interviews, regulatory compliance, and other aspects of quality systems. Selected candidate will have a good understanding of current Good Manufacturing Practices (cGMP), and quality assurance practices. If you are interested, please send your resume and salary requirements to jlane@smithhanley.com   Education:Associate Degree Reference Code:3021198 Email:Apply by Email