Quality Assurance Associate

Discovery Life Sciences; Northern (KY); Híbrido; USD 45 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Free dental and vision package

Life insurance

Disability coverage

401(k) match

Generous vacation and PTO

Parental/family leave

Professional development reimbursement

Team-building events

Employee Referral Program

Resumo da oferta

Discovery Life Sciences is seeking a Quality Assurance Associate to join our Global Quality & Regulatory team in a hybrid role, primarily based in Newtown, PA. You will apply ALCOA+ data integrity, GDP, and risk-based quality methods to review global scientific, technical, and quality records to ensure regulatory and customer requirements are met.

The ideal candidate has a biology/chemistry background, up to 2 years of QA or regulated experience, and familiarity with audits.

Qualificações

• Bachelor's degree in a scientific field and related experience may be considered.
• 0–2 years in Quality Assurance or regulated environments.
• Internship or lab experience in a regulated setting is a plus.
• Excellent MS Office skills required; familiarity with GDP and ALCOA+ is expected.
• Candidates with PMP/ASQ certifications are encouraged to apply.

Responsabilidades

• Review GxP-regulated documents for compliance, accuracy, and quality.
• Support audits by documenting requests and coordinating responses.
• Assist with CAPA tracking and quality investigations.
• Collaborate with global teams including Germany to ensure compliance.
• Develop controlled documents and participate in internal audits.

Conhecimentos

Attention to detail

Regulatory/GxP familiarity

Auditing experience

Communication skills

Formação académica

Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related scientific discipline

PMP certification or ASQ certifications

Ferramentas

MS Word

Excel

PowerPoint

OneNote

Descrição da oferta de emprego

Newtown Location
642 Newtown Yardley Rd
Newtown, PA 18940, USA

Newtown Location
642 Newtown Yardley Rd
Newtown, PA 18940, USA

Discovery Life Sciences(Discovery)is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovationusing our Science at your Service TM business model.

Position Summary:

Discovery Life Sciences is seeking a Quality Assurance Associate to join our Global Quality & Regulatory team. This role plays a critical part in ensuring the integrity, accuracy, and compliance of laboratory and quality system documentation acrossSpecialty Lab Services.Through the application of ALCOA+ data integrity principles, Good Documentation Practices (GDP), and risk-based quality methodologies, the Quality Assurance Associate will perform independent reviews ofglobalscientific, technical, and quality records to ensure they meet regulatory requirements, customer expectations, and internal quality standards.The QA Associate will alsobe providinglocal internal and external audit support at our Newtown, PA location.

This position offers an excellent opportunity for recent graduates or early-career professionals to gain meaningful experience in a regulated biotechnology environment while contributing directly to Discovery Life Sciences' missiontoimproving patient outcomes. The ideal candidate is detail-oriented, collaborative, and passionate about quality and compliance.

A Day in the Life of aQA Associateat Discovery Life Sciences:

• Review scientific, technical, and quality documentation to ensure compliance with GxP requirements, internal procedures, and industry standards.
• Partner with laboratory, operations, and quality teams tofacilitatetimelydocument review and approval processes.
• Support customer and regulatory audits by preparing documentation, tracking requests, andassistingwith auditlogistics.
• Conduct audits of study binders and quality records to verify completeness, traceability, andinspectionreadiness.
• Assistwith quality investigations, CAPA follow-up activities, and continuous improvement initiatives.
• Collaborate with global team members, including colleagues in Germany, to support quality system effectiveness and compliance.

Must-HaveQualifications(Education, Skills, Experience):

• Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, ora relatedscientific discipline. Related experience or degree fields may be considered.
• 0 to 2 years of experience in Quality Assurance, laboratory,laboperations, pharmaceutical, biotechnology, CRO, or other regulated environments.
• Internship, co-op, undergraduate research, or laboratory experience in a regulated setting.
• Experience supporting audits, document control activities, or quality systems is a plus.
• Must have excellent Microsoft Office skills (MS Word, Excel, PowerPoint, One Note, etc.)
• Basic understanding of GxP requirements, Good Documentation Practices (GDP), and ALCOA+ data integrity principles.
• PMP certification or certifications from the American Society for Quality (ASQ) or similar professional organizations.
• Strong attention to detail with the ability to review technical and scientific documentation for accuracy, completeness, and consistency.
• Recent graduates with relevant coursework and laboratory experience are encouraged to apply.

Key Responsibilities:

Document Review & Compliance

• Review and approve GxP-regulated documents for compliance, accuracy, completeness, and quality.
• Perform quality reviews of study protocols, protocol amendments, analytical plans, and bioanalytical reports.
• Review assay development reports, validation plans, and validation reports to ensure compliance with regulatory and internal requirements.
• Assess change controls and risk management documentation forappropriate impactassessment, implementation, and documentation.
• Review computerized system validation documents to ensure systemsremainfit for intended use andmaintainedin a validated state.
• Conduct audits of study binders and associated records to verify completeness, traceability, and audit readiness.
• Identifyquality, compliance, anddocumentationissues and trends, providingtimelyfeedback and resolution support.

Audit Support

• Assistwith pre-audit preparation and documentation requests.
• Support customer, client, and regulatory audits by documenting requests, retrieving records, coordinating responses, andfacilitatingaudit activities.
• Provide post-audit support, including documentation of findings and review of audit responses where applicable.
• Track corrective and preventive actions (CAPAs) through completion and closure.

Quality Systems & Continuous Improvement

• Support continuous improvement initiatives that strengthen quality systems, documentation processes, and compliance effectiveness.
• Participate in internal audits asappropriate.
• Develop procedures, work instructions, job aids, and other controlled documents.
• Support departments during implementation of quality-related activities and initiatives.

Compensation and Benefits:

Discovery Life Sciences is committed to fair andequitablecompensation practices, and we strive to provide employees with total compensation packages that are market competitive.For this role, the anticipated base pay range is $45,000-$60,000 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 onvarious 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.
• 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 certificationsand tuition.
• Collaborativeand 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:

• Hybridschedule, working at least 3 days per week onsite inNewtown, PA
• Flexible work schedule,howevermust be willing to accommodatemultiple time zone including some early morning startsin order towork with the team in Germanyand be available on site for audits inNewtown, PA during regular businesshours
• Approximately5-10%domestic or internationaltravelrequiredfor mandatory site meetings and trainings

Qualifications

Skills

Behaviors

Motivations

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Education

Experience

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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