Quality Assurance Operations Specialist I

Quality Assurance Operations Specialist I - Contract - Philadelphia, PA

Proclinical is seeking a dedicated Quality Assurance Operations Specialist I to join a team in Philadelphia.

Primary Responsibilities:

This role will be instrumental in supporting day-to-day operations, ensuring the highest standards are met. This position requires a collaborative and organized individual who thrives in a fast-paced environment and is eager to learn and take ownership of their responsibilities.

Skills & Requirements:

• Bachelor's degree in Biological sciences, engineering, or related field.
• Proficient experience in GMP QA/QC.
• Familiarity with electronic QMS systems like MasterControl or Veeva.
• Knowledge of GMP, GDP, and FDA quality systems.
• Strong communication skills and attention to detail.
• Ability to work effectively on multiple projects simultaneously.
• Comfortable in a fast-paced environment with changing priorities.
• Proficient with Microsoft Office Suite.

The Quality Assurance Operations Specialist's responsibilities will be:

• Review manufacturing batch records and labeling/packaging operations for timely product release.
• Support quality assurance processes, controls, and batch history files.
• Provide real-time, on-the-floor support for manufacturing production activities, ensuring compliance with GMP and GDP initiatives.
• Communicate standard work completion and address any hurdles.
• Collaborate with Contract Manufacturing Organizations (CMOs) and internal teams for efficient batch release.
• Release raw materials and manage inventory.
• Prepare and organize release documentation for approvals.
• Support internal audits and regulatory inspections.
• Participate in SOP revisions to enhance compliance.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonaldo at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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