Quality Assurance Associate

Software Guidance & Assistance, Inc. (SGA, Inc.); Morrisville (NC); Presencial; USD 39.000 - 52.000; A tiempo parcial

Descripción de la vacante

Software Guidance & Assistance, Inc. (SGA) is seeking a Quality Assurance Associate for a contract assignment with a BioTech client in Morrisville, NC.

The role emphasizes maintaining compliance and document control, interacting cross-functionally, and ensuring regulatory records (CLIA, CAP, NYS, CA) are accurate and up-to-date, while supporting QA processes and audits.

Formación

• Bachelor's degree or equivalent related experience within a quality assurance, compliance, document control or similar function of a biotechnology, clinical, or diagnostic laboratory.

Responsabilidades

• Maintain periodic review compliance by communicating and following up with document owners.
• Maintain quality document lifecycle through scanning, storing, and archiving in accordance with the FMI QMS.
• Interact cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
• Ensure records are kept under CLIA, CAP, NYS, and CA requirements and are attributable, legible, original, contemporaneous, and accurate.
• Review all Quality documents for clarity and alignment within operations.
• Ensure equipment standards are tested, calibrated, and standardized before patient testing.
• Assist with Lot-to-Lot validations of new reagents.
• May assist with nonconformance investigation and root cause analysis.
• May assist with incoming material review.
• May assist teams on internal audits.
• Other duties as assigned.
• An advanced degree without experience
• Support QA and document control processes for the project.
• Ensure documentation is maintained accurately and in compliance with regulatory requirements.
• Contribute to quality and compliance initiatives supporting business-critical deliverables.

Conocimientos

QA experience

Document control

Regulatory knowledge

HIPAA privacy

ASCP/AMT certification

Educación

Bachelor's degree

Descripción del empleo

Software Guidance & Assistance, Inc., (SGA), is searching for a Quality Assurance Associate for a contract assignment with one of our premier BioTech clients in Morrisville, NC.

Responsibilities

• Maintain periodic review compliance by communicating and following up with document owners.
• Maintain quality document lifecycle through scanning, storing, and archiving in accordance with the FMI QMS.
• Responsible for working and interacting cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
• Ensure that records are kept under CLIA, CAP, NYS, and CA requirements such as attributable, legible, original, contemporaneous, and accurate.
• Review all Quality documents for clarity and alignment within operations.
• Ensure that equipment standards are tested, calibrated, and standardized before patient testing.
• Assist with Lot-to-Lot validations of new reagents.
• May assist with nonconformance investigation and root cause analysis.
• May assist with incoming material review.
• May assist teams on internal audits.
• Other duties as assigned.
• An advanced degree without experience
• Support QA and document control processes for the project.
• Ensure documentation is maintained accurately and in compliance with regulatory requirements.
• Contribute to quality and compliance initiatives supporting business-critical deliverables.

Required Skills

• Bachelor's degree or equivalent related experience within a quality assurance, compliance, document control or similar function of a biotechnology, clinical, or diagnostic laboratory;
• Junior-level candidate with 1+ years of experience.
• Strong interest in Quality Assurance and compliance-related work.
• Document control experience is required and considered a dealbreaker.
• 1+ years of QA experience
• ASCP or AMT clinical laboratory scientist certificationExcellent attention to detail and multitasking skills
• Familiarity with MA & NYS regulations, CAP, and CLIA
• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem-solving with departments and colleagues
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow
• Demonstrated ability to consistently meet or exceed project deadlines
• Understanding of HIPAA and the importance of privacy of patient data
• Ability to work well under pressure while maintaining a professional demeanor.

Preferred Skills

• Prior experience in a regulated environment and Exposure to regulatory and compliance requirements

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/.

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.