Quality Assurance Specialist

Discovery Life Sciences; Huntsville (AL); Hybrid; USD 70,000 - 85,000; Full time

Benefits offered by this job

Dental & Vision

Life Insurance

Disability Coverage

401(k) Match

Paid Time Off

Professional Development

Employee Referral Program

Job summary

Discovery Life Sciences seeks a Quality Assurance Specialist to support quality/compliance across our Specialty Lab Services, including Flow Cytometry, Genomics, and Proteomics. You will assist with audits, supplier qualifications, change management, and CSV, ensuring adherence to GxP and 21 CFR Part 11.

The role requires a life sciences degree, 5+ years QA experience in regulated settings, and knowledge of ICH-GCP. Hybrid work in Huntsville, AL, with travel as needed.

Qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum 5 years of Quality Assurance experience in regulated scientific environments.
• Familiarity with Flow Cytometry in CAP/CLIA settings and understanding of ICH-GCP requirements.
• Strong knowledge of Quality Management Systems (QMS) and regulatory standards (FDA, ICH, MDR, IVDR, CAP/CLIA, GCP, GCLP, ISO 13485).
• Experience with audits (internal, supplier, external) and CAPA management.

Responsibilities

• Maintain, monitor, and support adherence to the Quality Management System (QMS) across Discovery's Specialty Lab Services operations.
• Ensure compliance with applicable regulations and internal quality procedures (GCP, GCLP, CAP/CLIA, ISO 13485, ISO 15189).
• Provide quality guidance and training on documentation practices, quality standards, and compliance expectations.
• Serve as the primary QA partner for Flow Cytometry operations and collaborate with lab SMEs to embed quality requirements.
• Lead and support external audits and internal audits; drive audit readiness and issue resolution.
• Facilitate investigations, CAPA, deviations, and continuous improvement using root-cause analysis.
• Oversee Change Management and CSV activities to ensure 21 CFR Part 11 and GxP compliance.
• Manage US supplier qualification activities and conduct supplier audits.

Education

Bachelor's degree in Life Sciences

Certified Quality Auditor (CQA) or comparable quality certification

Job description

Discovery Life Sciences is a global leader in biospecimens and specialty lab services, enabling the discovery and development of therapeutics and diagnostics that improve patient outcomes. Through a comprehensive suite of specialty lab services in flow cytometry, genomics, proteomics, cell biology, and molecular pathology, Discovery delivers critical data and insights for biomarker discovery and both retrospective and prospective clinical trials. With a vision to be the most trusted partner in life science research and clinical development, Discovery Life Sciences is committed to advancing life sciences and transforming lives. Visit www.dls.com for more information.

Position Summary:

Discovery is looking for a talented Quality Assurance Specialist to play a key role in supporting the quality and compliance of Discovery’s Specialty Lab Services operations. In this role, your primary responsibilities will include providing routine support to advanced technical laboratories (Flow Cytometry, Proteomics, Genomics) which perform research and retrospective/prospective clinical testing, supporting and hosting external audits, managing supplier qualification activities in the US, and providing oversight of change management processes.
This role requires some experience with Flow Cytometry to enable effective collaboration with laboratory SMEs and practical application of quality requirements within the technical environment. As part of the Global Quality & Regulatory team, this position also supports investigations and CAPAs, computerized systems validation, documentation and data review, and continuous quality improvement.

Must-Have Qualifications (Education, Skills, Experience):

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Certified Quality Auditor (CQA) or a comparable professional quality certification is preferred.
• Minimum of 5 years of Quality Assurance experience within pharmaceutical, biotechnology, clinical research, clinical laboratory, diagnostic, CRO, or other regulated scientific environments.
• Strong hands‑on experience supporting GCP‑regulated activities with a demonstrated understanding of ICH‑GCP requirements and quality principles.
• Familiarity with Flow Cytometry (preferably in a CAP/CLIA setting), acquired through direct laboratory experience in a technical role or as quality support.
• Strong working knowledge of Quality Management Systems (QMS) and applicable regulations and standards, including FDA and ICH requirements, EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), CAP/CLIA, GCP, GCLP, and ISO 13485.
• Robust Audit Experience:
• Supporting audits - pre, post, and in process audit requests
• Hosting external audits (sponsor, health authority, or accreditation audits)
• Conducting internal audits and supplier/service provider audits
• Strong background and expertise in change management, and ability to clearly communicate complex quality principles to diverse stakeholders.
• Prior experience with NCEs, deviations, investigations/root cause analysis, & CAPA management.
• Working knowledge of Computerized Systems Validations (CSVs) including planning, execution, documentation, and ensuring compliance with regulatory requirements (e.g. 21 CFR part 11, GxP) preferred.

Key Responsibilities:

Quality Management System (QMS) & Compliance

• Maintain, monitor, and support adherence to the Quality Management System (QMS) across Discovery's Specialty Lab Services operations.
• Ensure compliance with applicable regulations, accreditation standards, customer requirements, and internal quality procedures, including GCP, GCLP, CAP/CLIA, ISO 13485, and ISO 15189.
• Maintain accurate and complete quality records in accordance with regulatory and company requirements.
• Provide quality guidance and training to laboratory personnel on documentation practices, quality standards, and compliance expectations.

Flow Cytometry & Laboratory Quality Support

• Serve as the primary Quality Assurance partner for Flow Cytometry operations, providing day-to-day quality support and consultation.
• Collaborate with laboratory SMEs to ensure quality requirements are effectively integrated into laboratory processes while maintaining practical, risk‑based solutions.
• Support laboratory quality activities including deviations, non‑conformances, investigations, CAPAs, training, metrics, document review, and compliance initiatives.
• Support future harmonization and expansion of Flow Cytometry services across global laboratory locations.

Audit & Inspection Readiness

• Lead and support external sponsor, customer, accreditation, and regulatory audits, including preparation, hosting activities, document retrieval, issue resolution, and post‑audit follow‑up.
• Conduct and participate in internal audits to assess compliance and identify opportunities for continuous improvement.
• Drive audit readiness initiatives to ensure laboratories remain inspection‑ready at all times.

Investigations, CAPA & Continuous Improvement

• Facilitate and support investigations related to deviations, non‑conformances, quality events, and compliance concerns.
• Partner with cross‑functional teams to perform root cause analyses and develop effective corrective and preventive actions (CAPAs).
• Monitor CAPA implementation and effectiveness to ensure sustainable resolution of quality issues.
• Identify quality trends, risks, and opportunities for process improvement through analysis of quality metrics and operational data.

Change Management & Computerized Systems Validation

• Provide global oversight of the Change Management process, ensuring changes are appropriately assessed, documented, approved, implemented, and monitored.
• Evaluate the quality and regulatory impact of proposed changes and provide guidance on mitigation strategies where necessary.
• Support Computerized Systems Validation (CSV) activities and IT Change Control processes, ensuring compliance with applicable GxP and 21 CFR Part 11 requirements.
• Review validation documentation and provide quality guidance to laboratory and technical stakeholders.

Supplier Quality Management

• Manage U.S. supplier qualification activities and conduct supplier audits to ensure compliance with regulatory, quality, and contractual requirements.
• Support ongoing supplier performance monitoring and global supplier qualification initiatives.
• Partner with internal stakeholders to assess and manage quality risks associated with vendors and service providers.

Documentation & Quality Review

• Review and approve SOPs, forms, validation documents, study documentation, laboratory data, reports, and analytical plans for accuracy, completeness, and compliance.
• Ensure controlled documents remain current, properly maintained, and aligned with regulatory and business requirements.
• Support document management activities within electronic QMS platforms and controlled documentation systems.

Compensation and Benefits:

Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $70,000 - $85,000 annually. Candidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate’s offer letter. The exact base pay offered for this role will depend on various factors, including the candidate's qualifications, skills, and experience. Your annual salary is only one part of your total compensation package. Other benefits include:

• Competitive salary and benefits package options, including a free dental, vision package, life insurance, and disability coverage which start on your first day of employment.
• This role is also eligible to earn performance‑based incentive compensation, which may include cash bonus(es). These incentives are discretionary.
• 401(k) match program which starts on your first day of employment.
• Time away from work (Generous vacation and paid time off, paid parental leave, paid family leave, etc.).
• Professional development opportunities and reimbursement for relevant certifications and tuition.
• Collaborative and inclusive work environment that values diversity.
• Team‑building activities and social events.
• Employee Referral Program and Colleague Recognition Program.

Location, work hours, and application details:

• Hybrid if within commuting distance of Huntsville, AL; Remote candidates considered within 4-hour drive of Huntsville.
• Flexible work schedule, start time between 7am and 9am local time
• Up to 10% domestic and international travel required for mandatory site meetings and trainings

We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success.

Discovery Life Sciences values building direct relationships with candidates and primarily manages its hiring process internally. While we may engage select recruitment partners for specific searches, we do not accept unsolicited resumes or candidate submissions from agencies or recruiters. Any unsolicited resumes submitted to Discovery Life Sciences will be considered the property of Discovery Life Sciences, and the company assumes no obligation to pay any associated fees or commissions.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.