ESSENTIAL FUNCTIONS
• Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, procedures, test plans and summary reports. This responsibility includes IQ/OQ/PQ, method validation approvals and conducting data integrity audits.
• Responsible for QA review and approval of change control requests (e.g., DCRs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable.
• Performs QA review of change controls.
• Provides QA support for all facility departments. Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensures they are resolved in a compliant manner. Expected to work cross-functionally and participate in complex projects.
• Responsible for QA review and approval of deviations.
• Responsible for QA review and approval of materials and products to include commercial product review and release.
• Responsible for QA review and release of in-process and finished product.
• Perform other duties as necessary to ensure the efficient and effective operation of the department.
• Work closely with senior management within the department and throughout the facility to ensure quality requirements are met.

EDUCATION/EXPERIENCE REQUIREMENTS
• A Bachelor’s degree in Engineering or Life Sciences is preferred.
• Three to five years of experience in quality assurance/quality control and/or at least two years in pharmaceutical or related manufacturing environment,
• Knowledge of chemistry and QC laboratory operations is highly desirable.
• An equivalent combination of education, experience and training may substitute.

Qualifications
Attributes
Computer/Software Skills
Requires proficiency in basic MS Word, Outlook, Excel
Compliance Knowledge
Requires ability to deal appropriately with regulatory agencies
Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP
General Competencies
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong critical reasoning and decision making skills
Requires strong teamwork and facilitation skills
Written Communication
Requires ability to interpret / write general business documents
Problem Solving
Requires ability to solve routine and complex problems
Level of Supervision
Requires direct supervision
Impact of decisions
Impacts multiple departments