Senior Quality Assurance Analyst
1 week ago
Are you ready to take your Quality Assurance expertise to the next level? Join us in a critical role as a Plant Quality Assurance Specialist (PQA) working 100% onsite with a rotating 12-hour shift schedule (6:50 AM – 7:00 PM).
This role demands a high level of autonomy and attention to detail, making real-time quality decisions in a fast-paced environment
Key Responsibilities:
- Quality Oversight: Provide essential quality support to bulk drug manufacturing operations, ensuring that products meet cGMP standards and regulatory requirements.
- GMP Documentation: Oversee and review critical GMP documents, including batch records, logbooks, attachments, work orders, and related records, ensuring data integrity and compliance.
- On-the-Floor Presence: Be actively present on the manufacturing floor, collaborating closely with the production team and ensuring all procedures and quality requirements are upheld.
- Risk Management: Identify and escalate potential risks in quality, compliance, supply, and safety to management in real-time.
- Documentation Integrity: Ensure complete, accurate, and compliant documentation of production records and testing results.
Ideal Candidate Profile:
- GMP Expertise: Demonstrated experience working within a cGMP environment, with the ability to navigate ambiguity and prioritize effectively in a dynamic, high-stakes setting.
- Collaborative Mindset: Proven ability to work both independently and within a team, collaborating across functional areas to maintain high standards.
- Microsoft Office Proficiency: Skilled in using Outlook, Word, Excel, PowerPoint, and MS Teams to document, communicate, and collaborate effectively.
- Attention to Detail: Strong focus on quality assurance, data integrity, and documentation.
- Educational Background: Bachelor’s degree preferred, plus at least two years of quality or manufacturing experience in a cGMP environment.
If you're a proactive, detail-oriented professional with a customer-focused approach to Quality Assurance, we'd love to connect. Let's make a difference in drug substance manufacturing quality together
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