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.