Quality Assurance Associate

Job Description

Job Description

About Discovery Life Sciences:

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 innovation using our Science at your Service TM business model.

Position Summary:

Discovery is looking for a talented and passionate System Administrator to join our dynamic IT team. As a System Admin, you will play a pivotal role in designing and developing cutting-edge software solutions that will revolutionize the industry. We offer an exciting and collaborative work environment where you can unleash your creativity and make a real impact.

A Day in the Life of a Quality Assurance Associate at Discovery Life Sciences:

• Review batch records, manufacturing documentation, and supporting quality records to ensure GMP compliance and readiness for product release.
• Partner with Manufacturing and Operations teams to resolve documentation discrepancies, clarify deviations, and ensure all records are completed accurately and in a timely manner.
• Issue, control, and maintain GMP documentation within the Quality Management System, ensuring adherence to Good Documentation Practices (GDP).
• Support product release activities by coordinating required testing, reviewing analytical results, and verifying that all release criteria have been met.

Required Qualifications (Education, Skills, Experience):

• Bachelor’s degree within life sciences or a related scientific discipline preferred
• At least 2 years’ of experience in Quality Assurance, Quality Systems, or related quality function in a GMP regulated environment
• Experience reviewing and approving GMP-controlled documentation required, including batch records, manufacturing records, or product release documentation
• Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Strong attention to detail and ability to prioritize multiple tasks
• Excellent computer skills and MS Office proficiency (including MS Word and Outlook)

Key Responsibilities:

• Perform issuance, review, approval, and control of GMP-quality documentation, batch records, and associated records.
• Conduct thorough document reviews to ensure compliance with GMP, GDP, internal procedures, and regulatory requirements.
• Support product release and disposition activities through review of manufacturing, testing, and quality documentation.
• Collaborate with Manufacturing, Operations, Collection Centers, and external partners to resolve documentation issues and quality concerns.
• Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with applicable regulatory standards.
• Assist with environmental monitoring, sample retention, document control, and other quality assurance programs as assigned.
• Support quality training initiatives and educate employees on quality expectations, regulatory requirements, and best practices.
• Identify, escalate, and track quality events, deviations, and compliance risks to ensure timely resolution.
• Serve as an advocate for quality throughout the organization and promote a culture of continuous improvement and compliance.

• Support internal audits, inspections, and quality initiatives as needed.

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 $65,000 - $72,000 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.
• 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:

• 100% onsite – Quincy, MA
• 4 day work week: Monday – Thursday 7am – 5:30pm eastern time
• Less than 5% domestic or 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.