Quality Assurance Specialist (Part-Time)

Job Summary:

Pangea Laboratory is seeking a dynamic individual to become an integral part of our Quality Assurance Team. The Quality Assurance Specialist is responsible for supporting overall quality standards. This role involves monitoring quality control processes conducting audits and ensuring compliance with laboratory standards and regulations. Supports Laboratory Management to identify areas for improvement and develop strategies to enhance overall quality. This position is part-time with a schedule of M W F 8:30am-5pm onsite.

Essential Duties and Responsibilities:

• Manage document control for all quality-related records and procedures.
• Conduct internal audits to ensure compliance with regulatory standards (e.g. CLIA CAP)
• Coordinate proficiency testing programs and analyze results to identify areas for improvement.
• Ensure all regulatory licenses are up to date.
• Investigate and document non-conformances root cause analysis and corrective and preventative actions (CAPA).
• Collaborate with lab management to address quality issues and drive continuous improvement.
• Prepare and present quality metrics and reports for management review.
• Train and provide orientation to all new hire personnel; review all associated training documents; and monitor the competency process of testing personnel.
• Be familiar with laboratory protocols and procedures for specimen processing operating equipment and instruments maintenance of designated laboratory environment and instruments and data analysis.
• Conduct/coordinate with internal and external audits and report instances of noncompliance to the appropriate compliance personnel. Participate in all Quality Assurance and Quality Improvement efforts as applicable.
• Comply with all policies and regulations put in place by Pangea Laboratory County State Federal CAP CLIA/CMS and HIPAA.
• Follow Pangea Laboratory health and safety policies and procedures and are responsible for reporting violations.
• Perform other related duties as required assigned and/or delegated by the Laboratory Supervisor/ Manager and/or Laboratory Director.

Education:

Bachelor of Science degree from an accredited institution with a focus in chemical biological clinical or medical laboratory science or medical technology.

Experience:

Must have a minimum of three (3) years of experience in a clinical or diagnostic laboratory or in a quality assurance or quality control role.

Must be proficient in MS Applications (Word/Excel/PowerPoint/Outlook).

Skills and Attributes:

1. Deep knowledge of quality assurance terminology software methods and tools.
2. Excellent analytical problem-solving and decision-making skills.
3. Experience in compliance and/ or regulatory and current knowledge of laboratory standards and regulations
4. Demonstrate good leadership qualities.
5. Have the ability to read write (legibly) and speak the English language.
6. Demonstrate autonomy and possess time management skills.

Computer Skills:

1. Knowledge of basic computer skills such as Microsoft Office Suite to include Excel and Word.
2. Previous experience with Laboratory Information Systems preferred.

Language Skills:

1. Ability to effectively communicate with management and team members.
2. Ability to read and understand laboratory documents pertaining to testing and routine tasks.

OSHA Risk Category:

Category I: Job Tasks which involve exposure to blood body fluids tissues hepatitis viruses or human immunodeficiency viruses.

Safety:

1. Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions as well as correcting unsafe work habits and practices and/or bringing to the attention of the Laboratory Supervisor and/or Laboratory Director Chief Executive Officer any practice or condition that may be detrimental to the safety and health of employees.
2. Responsible for compliance to all safety policies of the Pangea safety program.
3. Follows procedures for biohazardous/hazardous waste disposal.
4. Utilizes appropriate infection control practices such as handwashing proper glove disposal use proper personal protective equipment and work practice controls.
5. Maintains proper body mechanics and utilizes safe work practices.

Regulatory and Compliance:

1. Maintain compliance for all applicable statutory and regulatory requirements for international federal and state requirements including but not limited to California Labor Laws OSHA Clinical Laboratory Improvements Amendments (CMS) Americans Disabilities Act Health Insurance Portability and Accountability Act (HIPAA/Omnibus) College of American Pathologists California State Department of Public Health.
2. Always exhibits ethical and professional behavior.
3. Always maintains patient confidentiality (HIPAA).

About us:

Pangea Laboratory is a California-based diagnostics company founded in 2014. We focus on the precise early detection of emerging diseases. Our mission is to have a positive impact on human life by providing biomedical communities with reliable and high-quality testing services delivering the data they need to diagnose and treat diseases in an effective and timely manner. Named a Top Workplace by the OC Register Pangea Laboratory continues to be a place where employees feel engaged connected and energized about their work. If you are passionate about helping people in advancing science and working with awesome teams in a fast-growing company we want to speak with you!

Compensation:

The estimated base compensation range for this position is $28 to $36 per hour at the time of posting. Actual compensation details will be provided in writing at the time of offer if applicable and is based on several factors we believe fairly and accurately impact compensation including geographic location experience knowledge skills abilities and other job permitted factors.

Pangea Laboratory also offers competitive perks including:

- EAP Sessions

- Paid Sick Leave

- 401(K) Plan

- Complimentary fruit snacks and beverages

- Complimentary catered lunches on Thursdays

Equal Employment Opportunity Employer:

Pangea Laboratory welcomes candidates of all backgrounds. These include sex age color race religion marital status national origin ancestry sexual orientation gender gender identity gender expression physical & mental disability medical condition genetic information military and veteran status or any other protected status as defined by federal state or local law.

Location:

Onsite Pangea HQ 14762 Bentley Cir. Tustin CA 92780

Disclaimer:

At Pangea Laboratory we take the integrity of our hiring process seriously. Please be aware of fraudulent recruitment activities that may use our name to deceive job seekers. We will never ask for payment sensitive personal information or financial details during the recruitment process.

All legitimate communications will come from an official Pangea Laboratory or TriNet Hiring email address. If you are contacted by anyone claiming to represent us using a free email service (e.g. Gmail Yahoo Hotmail) or asking for payment please treat this as fraudulent and report it immediately to