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Quality Assurance Specialist

2 months ago

Fort Washington, Pennsylvania, United States Integrated Resources Full time

Integrated Resources is seeking a highly skilled Quality Assurance Analyst to provide daily support to our manufacturing site. The successful candidate will be responsible for ensuring compliance with internal and regulatory cGMP and CFR requirements. Key responsibilities include:

**Quality Assurance Support**

* Provide daily 'Shop Floor QA support to warehouse, bulk manufacturing, and packaging lines.
* Perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
* Participate in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's).

**Investigations and Compliance**

* Conduct, write, review, and approve Investigation Protocols and reports.
* Perform or support activities related to Line Audits, Line or Area Cleaning Verifications.
* Provide support to Consumer Complaint investigations.

**Leadership and Collaboration**

* Provide training and direction as needed to new employees.
* Team with Department members for process feedback and continuous improvement opportunities.

**Requirements**

* 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement.
* Technical B.S. or B.A. College Degree in Science is preferred.
* Active cGMP Interpretation and Application Experience.
* Demonstrated leadership- possesses the ability to lead a team.
* Strong Organizational Skills.
* Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation).
* Problem Solving/Investigation Experience.
* Expertise in Handling Multiple Priorities.
* Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance.
* Investigation Documentation.
* Experience with Liquid Dose processing and packaging technology preferred.
* Validation Experience preferred.