The Quality Assurance Specialist provides support for the Quality Management System, performs quality functions and procedures, applies investigative and data collection techniques, and works to resolve process issues by reviewing standards and procedures of operation and performing audits as required.
Summary of Key Responsibilities:
- Monitor conformance to GCLP under Quality System guidelines ensuring compliance with ISO standards in the operational processes on a daily basis
- Monitor the implementation of Standard Operation Procedure (SOP) and update the SOPs in collaboration with other departments as needed
- Monitor and control acceptance of incoming materials and equipment
- Perform internal audits
- Represent the clinical lab during external audits
- Control qualification of suppliers
- Control validation of equipment qualification
- Control in-house calibration of measuring equipment and coordinate external calibration activities
- Ensure QA documentation compliance
- Work closely with R&D and Clinical in identifying the needs of validation and perform testing on operation process, materials or lab equipment as needed
- Maintain and update documents such as QA files, QC inspection records, validation documentation, supplier notification, internal change notification, customer complaint history, and testing/validation reports
- Participate in and support documentation for regulatory audits, internal audits, management reviews, and supplier evaluation meetings
- Coordinate change control procedures and SOP administration
- Coordinate the logging and reviewing of complaints
- Ensure the maintenance of QA records
- Coordinate the maintenance of calibration and qualification records
- Coordinate maintenance of QA related equipment and measuring devices
- Maintain quarantined devices as necessary
- Participate in corrective and preventive action (CAPA) activities
- Participate and lead the CAPA related investigations and maintain CAPA records as required
- Report adverse events
- Implement design control and verification and validation strategies in compliance with relevant regulatory guidelines and with minimal supervision
- Participate in verification and validation activities
- Perform such other duties and responsibilities that are consistent with the role of a Quality Assurance Specialist or as may be assigned from time to time
Required Qualifications and Skills:
- B.S. in Life Sciences or an equivalent combination of commercial experience and formal education
- 1-3 years’ clinical lab experience
- 3 years’ experience working in a regulated environment in the biomedical or pharmaceutical industry
- Experience operating in an ISO15189 and/or CLIA regulated environment with a comprehensive working knowledge of CLIA regulations
- Proven experience with auditing and currently pursuing or possessing certification as an auditor
- Proficient in Microsoft Office (Excel, Word, Project, PowerPoint)
Budget managed (if applicable):
Skills & Capabilities:
- Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
- Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities.
- Demonstrates strong development, management and leadership skills with the ability to think independently.
- Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions
- Ability to produce quality written work, such as, technical reports, protocol and plans.
- Ability to skillfully present work and communicate ideas effectively to a multi-disciplinary teams.
- Ability to understand complex system interactions and the effect on analytical performance.
- Strong scientific/technical aptitude
- Exemplary customer service and interpersonal skills
- Strong leadership skills
- Good visual inspection skills combined with tolerance for repetitive work
- Strong verbal and written communication skills
- Ability to multitask and prioritize to meet deadlines
- Ability to work both independently with minimal supervision as well as in a team environment
- An eye for detail and commitment to high quality data
- Continuous learner with a keen appetite for cross-disciplinary work
- Flexibility and a “can do” attitude
- Entrepreneurial thinking and work ethic
- Not Required