Sr Quality Assurance Engineer
Brooksville, FL 34604 US
Sr. Quality Assurance Engineer
Title: Pharmaceutical Senior Quality Assurance Engineer
Location: Brooksville, FL
Shift: Mon-Fri 8am-5pm
Salary: 90k and up based on experience (Benefits Offered)
Employment Type: Direct Placement
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
This position is primarily responsible for Key Quality Systems such as Change Control, Event Management, CAPAs, Test Data Analysis/Certificates, Incoming Materials receipt and release, Manufacturing Record review and release, Trend Analysis, Complaint Handling & Internal Quality Auditing.
The position is responsible for the overall Quality Assurance review of all technical documents, as they relate to a) process improvement projects; b) all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems e) Event Management and complaint investigation reports.
- Management of the Change Control, Event Management and CAPA systems for all excursions generated during GMP activities; works with responsible parties to ensure timely completion.
- Manages incoming QA inspection and release of materials, Certificates for all GMP testing, including release and stability assays, and validation activities.
- Supports various other QA activities which include document review and approval of Executed Batch Records, specifications for API, raw materials, finished products and labeling, validation protocols and reports.
- Conducts and maintains internal audits and performs trend analysis for various Quality Systems.
- Project management and support of validation and quality system projects.
- Critical responsibilities of this position are the timely Quality Assurance data review and data generation to support validation activities, drug development, issuance of certificates of analysis as pertains to clinical trials and commercial market.
- The responsibilities of this position may be expanded to meet evolving Quality and Compliance needs, provided adequate training for these responsibilities is documented.
- Reports to the Manager of Quality.
- Bachelor s degree and a minimum of 6 years related experience in Quality Assurance and/or cGMP
- Experience in a cGMP regulated pharmaceutical environment
- Experience with Microsoft applications (Preferred)
- Experience with CSV Preferred
- Experience with Root Cause Analysis and authoring Complex Technical Investigations
- Good verbal and written communication skills
- Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
- Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds)
- Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
- Must successfully complete all material handling training/verification as part of ongoing training.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.