Quality Assurance Specialist

QA Specialist

Title: QA Specialist
Location: Brooksville, FL
Industry: Pharmaceutical
Salary: $65k and up depending on experience
Employment Type: Direct Placement

Client Overview:
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.

Position Overview:
Responsible for developing, maintaining, and complying with company quality assurance standards.

Responsibilities:

• Develop specifications for raw materials, components, intermediate products, and Finished Drug Product.
• Plan, execute, and oversee inspection and testing of product to confirm quality and conformance to specifications and test methods for raw materials, components, intermediate products, and Finished Product.
• Monitors applicable pharmacopeias to assure timely implementation of method changes as applicable.
• Provide QA support during investigations efforts on quality events, including investigation technical writing.
• Review and approve applicable quality events ensuring appropriate CAPAs are identified and implemented.
• Identify and implement quality continuous improvement processes (both internally and externally) which increases efficiency and maintains high quality standards.
• Review and approve master and executed batch records.
• Provide quality assurance GMP oversight to manufacturing, QC testing and batch release.
• Provides visibility to cross-functional team to qualify, transfer and implement changes.
• Review and approve Validation, Qualification and Technology Transfer Protocol and Reports for Equipment, Process, Facility, and IT systems.
• Ensure systems are in compliance with current SOPs.
• Interact with multiple business functional areas (e.g., Quality Control, Operations, Facilities, etc.), ensuring GMP quality compliance and best practices are met.
• Report quality issues to ensure resolution in accordance with company guidelines and external regulatory requirements
• May perform additional duties as required.

• Bachelor s degree in Science preferred.
• 5+ years of quality and/or manufacturing experience in a pharmaceutical or biotech environment.
• Expertise in U.S. and international GMPs. Must understand standards of practice for GMP training.
• Previous experience in quality assurance or a similar field.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Solid knowledge of relevant regulatory standards.
• Good communication skills, both verbal and written.
• Committed to the concept of team and working within the framework of the company organization
• Excellent data collection, analysis skills, and attention to detail.
• Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)

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.

ADA/EOE
#LI-SRG11