Job Description

The Operations-Compliance Specialist utilizes deductive reasoning, interviewing skills and technical knowledge to perform investigations to find causes of aberrant events and circumstances impacting the products. The role work independently in the resolution of quality related issues by gathering relevant information, determining the accurate cause and defining appropriate corrective/preventive actions to prevent recurrence.

Essential Functions:

• Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Performs interviews and schedule follow-up meetings in response to investigations.

• Supports the business through schedule/timeline adherence of investigations closures to allow for timely new product launches, and batch releases.

• Perform gap assessments and root cause analysis evaluations to determine the exact cause of incident

• Identify and resolve objectionable cGMP issues which may impact product quality and escalate the issues to supervisor in a timely manner.

• Writes investigation reports in a clear and concise manner to withstand regulatory requirement.

• Prepares weekly/monthly status reports for departmental updates/meetings.

Additional Responsibilities:

• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.

Education:

• Bachelors Degree (BA/BS) Chemistry, Pharmaceuticals, Biology or a Engineering - Required

Experience:

• 2 years or more in Preferable working in cGMP regulated pharmaceutical particularly in operations

Specialized Knowledge:

• Working knowledge of pharmaceutical manufacturing, packaging and laboratory processes.

• Working knowledge of cGMPs as defined in the regulatory guidances.

• Working knowledge of Operations related Investigations.

Licenses: