Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The CQ Technical Data Reviewer-Incoming Materials reviews data from physical and dimensional test of commodities, including visual evaluation. In addition to data review, this individual could be responsible for inspection of commodities for visual and dimensional testing, as well as recording and processing data according to DEA, FDA, and ICH guidelines, as needed.
How You Will Achieve It
* Functions as a dedicated data reviewer for the Chemical Quality-Incoming Materials Lab.
* Prioritizes data review and testing with guidance from Data Coordinator.
* Assists in monitoring laboratory metrics associated with turnaround goals.
* As needed, performs visual and dimensional inspections for incoming material commodities required for testing, performs the analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.
* Provides support to assure lab safety-either through safe use of chemicals or recognition of hazards- and that the lab is compliant with DEA, FDA, OSHA, and ICH guidelines.
Qualifications
Must-Have
* Applicant must High School Diploma with six years of relevant experience.
* OR an Associate degree with four years of experience
* OR a Bachelor's degree with 0-2 years of experience.
* Knowledge of cGMPs and regulations outside of the US.
* Good communication, organization and computer skills are required.
* Knowledge of LIMS, Empower, and Microsoft Office programs is desired.
Preferred
* BS/MS in Science field
* Incoming Material Laboratory experience
* Minimum of 4 - 6 years experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.) or incoming material commodities (glass vials, stoppers, plastic bottles, printed material, etc).
PHYSICAL/MENTAL REQUIREMENTS
Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None
Work Location Assignment: On Premise