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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