QC Manager / Director – FILLED
The Wellington Group has been engaged to find a QC Manager / Director with experience ranging from batch release to QC inspections and OOS. Put your FDA regulated, QC Manufacturing experience to work in an exciting new job with great growth opportunity!
The QC Manager / Director, is responsible for various assigned cGMP compliance activities. This includes managing the following areas within the Quality organization: Raw Materials, in-process samples, stability studies, OOS, Batch Release, QC Inspection, QC Lab, and manufacturing floor quality process to oversee quality/compliance. These activities include the improvement, development and implementation of quality processes to ensure that the development, manufacture and distribution of products are in compliance with company policies and procedures, FDA, and other applicable regulatory agencies.
- Oversee QC Inspection group including incoming inspection, in-process testing, line clearance and final release of product
- Responsible for method development, validation and transfers
- Oversee and manage the OOS process
- Update and improve procedures that are used within the QC areas
- Conduct training of staff as required
- Managing the QC Laboratory and all routine testing process for raw materials, in-process and finished goods/products
- Ensure all Quality records pertaining to QC inspection and Batch Release are retained
- Ensure overall compliance level is appropriate for cGMP activities
The qualified candidate will have:
- BS Degree in Chemistry, MS Degree is preferred
- 5+ years of experience in OTC, Pharmaceuticals or Biologics in a cGMP manufacturing facility
- 3+ years in a supervisory role
- Hands-on experience with methods development and methods validation for analytical testing equipment and procedures
- HPLC, GC and Wet Chemistry expertise
- Knowledge of industry best practices for OOS and laboratory testing of manufactured products
Industry: QC Manager, QC Inspections, Batch Release, method validation, OOS, OTC, Pharmaceutical, stability testing, chemistry, HPLC, GC, Wet Chemistry
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)