Complaint Specialist

Morton Grove Pharmaceuticals, Inc. (MGP), located in Morton Grove, Illinois, has been a leading supplier of specialty and generic liquid pharmaceutical products for over fifteen years. The company owns, manufactures and markets over 120 drug products, both Rx and OTC, ANDA and non-ANDA. Its product line includes oral liquid and topical liquid generic pharmaceuticals, inhalations, as well as specialty pharmaceuticals and both Schedule II and Schedule III drugs. This extensive offering makes Morton Grove one of the largest suppliers of pharmaceuticals within its market class.
Responsibilities include:Product Complaint Handling:
- Receive, login, document investigate and closeout complaints as required by the applicable SOPs.
- Document all information, including conversations with complainants, sign, date and record the time the conversation took place.
- Coordinate all complaint related activities with other departments such as Regulatory Affairs, QC Lab, Stability, Document Control, Warehouse, medical consultants and complainants (primary/secondary) in order to close out the complaint in a timely manner as required by the applicable SOPs.Regulatory Audits/Consultant Audits/Consumer Audits:
- Participate in and facilitate regulatory, consultant/consumer audits as directed by the Head of cGMP Compliance & Audits.
- In the case of FDA audits, additional duties that fall outside of the realm of specific job responsibilities may be required as directed by upper management.Back up Duties Include:
-CAPA systems
-Training systems
-Internal audit
REQUIREMENTS
1.Basic Knowledge of Good Manufacturing Practices Regulations
2. A degree in pharmaceutical sciences, biological sciences, or a related field.
3.At least 1-2 years of work experience handling product complaints in the pharmaceutical field.
4. Documentation review experience is preferred.
5.Excellent technical writing and communication skills.
6. Working knowledge of Microsoft office programs such as Word and Excel.
&. High energy and a good degree of leadership qualities.
EEO/M/F/D/V