Quality Assurance Specialist

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 QA Specialist. This is a great opportunity for someone with a passion for quality and a desire to work in a fast-paced and dynamic environment. The QA Specialist is responsible for supporting quality systems, including document management and supporting client audits. Additionally, they assist Quality Management with departmental needs and support QA projects such as streamlining processes. Other responsibilities involve conducting internal audits and supplier evaluations.

A Day in the Life of a QA Specialist at Discovery Life Sciences:

• Review and approve laboratory data, standard operating procedures (SOPs), validation specifications and other quality documentation for completeness, accuracy, and compliance with regulatory standards (e.g. FDA, ICHGCP).
• Conduct audits and inspections to assess compliance with applicable regulations (e.g. FDA, ICH) and company procedures.
• Investigate nonconformances from established procedures and protocols and implement corrective and preventative actions (CAPA) to prevent recurrence.

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

• Bachelor’s degree with life sciences related major is preferred
• Generally, 5+ years of professional work experience in a Quality Assurance/Control role in the life sciences industry
• Knowledge of quality tools/concepts and their application such as Document Control/Change Control, Corrective/Preventive Action, Internal Audits, Computer System Validation, etc.
• Working experience with eQMS, ERP systems and other information systems
• Excellent attention to detail and strong analytical skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
• Ability to work independently and prioritize tasks in a fast-paced environment.

Key Responsibilities:

• Analyze data and generate reports to identify quality trends and areas for improvement.
• Participate in the development, implementation, and maintenance of quality systems and procedures.
• Participate in the development and implementation of quality improvement initiatives.
• Maintain a comprehensive understanding of relevant regulations and quality standards (e.g., FDA, EMA, ICH).
• Review training record compliance and report any discrepancies or shortcomings.
• Provide guidance and training to personnel on quality procedures, documentation practices, and regulatory requirements.
• Provide quality support to other departments, including laboratory personnel on quality-related matters.
• Participate in data analysis and reporting activities.
• Maintain accurate and complete quality documentation, ensuring proper recordkeeping.
• Support external audits and inspections.
• Perform internal and external quality audits, to ensure adherence to quality standards and contractual agreements.

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. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

Your annual salary is only one part of your total compensation package. Other benefits:

• Competitive salary and benefits package options including free medical, dental, vision, life, and disability 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, your BIRTHDAY, paid parental leave, paid family leave, etc.).
• Professional development opportunities and reimbursement for relevant certifications.
• 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:

• This is an onsite position located at Discovery’s headquarters in Huntsville, AL
• Flexible work schedule, start time between 7am and 9am local time
• Less than 5% domestic or international travel required for mandatory site meetings and trainings
• Applications for this position will be accepted until the role has been filled

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.