- Clinical research jobs
- Quality Specialist 1
Quality Specialist 1
IQVIA Holdings Inc.
Durham, North Carolina, United States
The Lab Quality Specialist is responsible for supporting lab quality control processes and improvements.
RESPONSIBILITIES:
- Responsible for providing Quality Control (QC) documentation support to operations.
- Performs QC review of lab documentation to ensure accuracy and compliance with applicable regulations and SOP's.
- Supports the review and update of QC related SOP's.
- Supports client audits by responding to routine inquiries and review of documentation ahead of audit to ensure readiness. Flags identified gaps to senior level staff.
- Supports QC educational programs such as in-house workshops, presentations, training and seminars for new hires and existing staff. Assists in drafting materials and lab staff training delivery.
- May work with management to update job training matrix.
- Coordinates and schedules all assigned QC projects with minor assistance from coworkers and manager.
- May track and report deviation QC trends to management.
- Participates in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
- Evaluates QC processes for gaps, recommend actions and communicate to management the analysis to support the continuous improvement of lab quality.
- Mentors and guides junior level staff. Supports the onboarding of new hires.
- Participates in continuing education through self-study, attending training sessions and lectures and meetings.
- Supports safety, quality, and 6S requirements and initiatives.
- Complies with company's procedures and regulatory requirements, as applicable.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor's Degree in medical technology or equivalent required.
- 1 year of experience in a regulated laboratory environment.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- Requires sound knowledge of laboratory quality systems and laboratory procedures.
- Requires sound knowledge of laboratory good documentation practices.
- Demonstrated ability to identify lab quality process gaps and propose basic resolution.
- Good computer skills using Microsoft Outlook, Word and Excel.
- Effective organizational and interpersonal skills.
- Effective communication and presentation skills.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Applicable certifications and licenses as required by local regulations.
Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. q2-solutions-eoe
Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.q2-solutions-covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $54,800.00 - $82,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Job posted: 2023-11-22