Quality Assurance Floor Associate

A Little About Us:

At BIOVECTRA, we are passionate about improving patient care by manufacturing better therapeutics. As a contract development manufacturing organization (CDMO), we partner with leading pharmaceutical and biotech companies worldwide. Our team combines a global reach with a strong sense of community, fostering a workplace built on teamwork, respect, professionalism, and quality. We embrace diversity and strive to maintain a welcoming and inclusive environment.

About the Role:

We are seeking an experienced quality professional to step into the role of Quality Assurance Floor Associate. You will be responsible to run and support activities within Quality Operations. You will work closely with Manufacturing and QC to provide QA oversight and support of GMP operations, facility inspections, GMP analytical data review and GMP batch record review.

Key Responsibilities:

• Providing consultation or advice in alignment with QA policies through on-the-floor presence
• Overseeing active operations on the floor to ensure patient safety is achieved and to ensure that GMP, GDP and Quality management systems are followed.
• Supporting the incident programs (deviation, laboratory investigation, CAPA, etc.), including reviewing, assessing the severity, and approving minor incidents and outcomes of Phase 1 OOS investigations.
• Escalation of major incidents (manufacturing and quality control) to Senior Quality Management.
• Participating in the investigations of major incidents.
• Participating in the internal audit program and supporting external audit requirements.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.
• Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
• Issuing, checking, and archiving QC notebooks.
• Supporting the manufacture of materials by conducting in-process quality inspections as required.
• Supporting Process lifecycle by reviewing and approving creation and changes to documents.
• Mentoring and training others with similar job duties as requested.

Enough about us. Let's Talk About You!

What You Bring to the Role:

• Post-Secondary Education, preferably a bachelor's degree in a scientific field
• Previous experience in a GMP manufacturing facility considered an asset
• Previous quality assurance experience considered an asset
• Proficient communicator, both written and oral.
• Able to work independently with minimal supervision as well as part of a team.
• Efficient at prioritization and scheduling.
• Basic computer skills (Microsoft Excel, Word, Outlook).
• Critical thinker.
• Effective presentation skills.
• Excellent interpersonal and team skills.

Why Join BIOVECTRA?

BIOVECTRA offers a competitive salary and benefits package including a healthcare and personal health spending account. You will have opportunities for professional growth in a collaborative and dynamic work environment.

If you are a motivated quality professional looking for a challenging and rewarding career, we encourage you to apply.