Job Description

ROLE SUMMARY

The QA Specialist I provides quality oversight and compliance support for operations including equipment and material preparation, aseptic compounding, filling, inspection, and packaging activities. This role applies knowledge of cGMP and regulatory standards to review documentation, monitor processes, and support investigations. QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement initiatives.

ROLE RESPONSIBILITIES

• Review and evaluate manufacturing and testing documentation to ensure 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, including 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 to maintain compliance standards.
• Collaborate with cross-functional teams to support process improvements and ensure adherence to regulatory requirements.
• Collect, analyze, and report departmental data to identify trends and support continuous improvement initiatives.
• Assist in training and mentoring QA colleagues, sharing best practices to strengthen team capability.
• Has the ability to understand and demonstrate proficiency in aseptic techniques and behaviors required in aseptic processing areas.
• 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, demonstrating accountability and ownership of quality standards.
• Review and edit SOPs, logbooks, and batch records for accuracy and regulatory alignment.

• Participates in internal GMP audits and supports customer and regulatory audits.
• Assists in review and editing of SOPs / Master Batch Records.
• Performs ERP transactions, as applicable
• Must be willing to work weekends and holidays as needed to support business initiatives

• Other tasks assigned by management requiring application of professional judgment and quality expertise.

BASIC QUALIFICATIONS

• Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 1 years experience in the Pharmaceutical or related industry
• The ideal candidate will possess a combination of relevant education, aseptic training and manufacturing/quality experience.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Demonstrated decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results and achievements
• Works in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have effective written and oral communication skills.
• Collects, researches, analyzes, and presents data information skillfully.
• Certified Quality Auditor (CQA) Certification preferred.

PHYSICAL QUALIFICATIONS

• Position requires vision acuity testing and onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
• The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area.
• It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

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