- Expiry Date: 30 September 2021
Provides support through quality review and approval of GMP Material & service non-conformances with suspected supplier root cause.
Provides quality oversight of supplier complaints.
Reviews and approves supplier investigations and CAPAs.
Represents Quality in cross-functional meetings and with suppliers.
Assist in resolution of supplier / material related issues as they arise.
May perform quality review for area documents including Standard Operating Procedures, Batch Records, Material Specifications, forms and logbooks
Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline, or its equivalent.
A minimum of 4 years with directly relevant experience in a regulated environment is required; biotech bulk and finished product manufacturing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of quality management systems, including TrackWise or Infinity, is desirable.
Past experience where one was required to work in a team-based environment with a diverse group of people.
Excellent writing and oral communication skills are required.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.