Quality Assurance Specialist I
About The Position
The QA Specialist I provides quality oversight and compliance support across equipment and material preparation, aseptic compounding, filling, inspection, and packaging. The role applies knowledge of cGMP and regulatory standards to review documentation, monitor processes, support investigations, and collaborate with cross-functional teams to maintain compliance and contribute to continuous improvement. The position requires proficiency in aseptic techniques and the ability to work in a Grade A/B classified area after completing aseptic gowning qualification. It requires onsite attendance and cannot be performed remotely or by telecommuting. The role may involve weekends and holidays as needed to support business initiatives, as well as multiple competing priorities and communications that may extend beyond core hours or time at the site.
Requirements
- Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or another science-related discipline, or at least 1 year of experience in the pharmaceutical or a related industry.
- Knowledge of cGMPs, including USFDA, Health Canada, PIC/S, and/or Eudralex requirements.
- Demonstrated decision-making ability related to incident investigation and corrective and preventive actions, with emphasis on quality, site priorities, results, and achievements.
- Ability to work in a team environment with own-team and interdepartmental teams.
- Ability to work under short timelines while maintaining quality work.
- Effective written and oral communication skills.
- Ability to collect, research, analyze, and present data and information skillfully.
- Ability to understand and demonstrate proficiency in aseptic techniques and behaviors required in aseptic processing areas.
- Ability to complete aseptic gowning qualification and work in a Grade A/B classified area.
- Ability to attend work onsite; the position cannot be performed remotely or by telecommuting.
- Ability to sit and stand, occasionally lift items up to approximately 25 pounds, and manage multiple tasks and competing priorities.
Nice To Haves
- Certified Quality Auditor (CQA) certification.
- A combination of relevant education, aseptic training, and manufacturing or quality experience.
Responsibilities
- Review and evaluate manufacturing and testing documentation for compliance with SOPs and cGMP requirements, applying professional judgment where needed.
- Provide quality oversight and guidance during shop-floor activities, inspection readiness, and in-process checks.
- Support deviation and laboratory investigations, change management, SOP revisions, and batch documentation review.
- Identify and escalate quality issues, and contribute to root cause analysis and corrective actions.
- Collaborate with cross-functional teams to support process improvements and regulatory compliance.
- Collect, analyze, and report departmental data to identify trends and support continuous improvement initiatives.
- Assist in training and mentoring QA colleagues and share best practices.
- Apply knowledge of manufacturing operations and quality procedures to proactively influence compliance outcomes.
- Communicate issues identified during batch production or record reviews promptly to management.
- Review and edit SOPs, logbooks, and batch records for accuracy and regulatory alignment.
- Participate in internal GMP audits and support customer and regulatory audits.
- Assist in reviewing and editing SOPs and Master Batch Records.
- Perform ERP transactions, as applicable.
- Complete other tasks assigned by management that require professional judgment and quality expertise.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
