Quality Specialist 1

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.