Quality Control Associate - Sierra Solutions Group

Durham, NC 27709

Job Summary
We are looking for a Quality Control Associate for our Life Sciences client.

Primary 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 SOPs.
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 quality control educational programs: 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 quality control 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 5S requirements and initiatives.
Complies with company's procedures and regulatory requirements, as applicable.

Education and Experience

Bachelor's Degree in medical technology or equivalent required.
1 year experience in a regulated laboratory environment.
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.

Source : Sierra Solutions Group