º¬Ðß²ÝÓ°Ôº

Quality Operations Specialist II - Night Shift - Contract - Philadelphia, PA

º¬Ðß²ÝÓ°Ôº is seeking a dedicated Quality Operations Specialist II to join an established biotech. This position is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and facility procedures.

Primary Responsibilities:

The successful candidate will interface with various functional groups, such as Manufacturing, Quality Control, and Document Control, to identify and report events like errors, deficiencies, discrepancies, deviations, and other observations to management.

Skills & Requirements:

• Bachelor's Degree in Science, Engineering, or a related technical discipline, or equivalent industry experience.
• Working knowledge of Good Manufacturing Practices (cGMPs) regulations.
• Ability to work in an aseptic processing environment.
• Strong administrative skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
• Excellent attention to detail.
• Knowledge of QMS systems is a plus.

The Quality Operations Specialist II's responsibilities will be:

• Maintain strict adherence to Good Manufacturing Practices (cGMPs) and facility protocols.
• Interface with Manufacturing, Quality Control, and Document Control to identify and report events such as errors, deficiencies, discrepancies, deviations, and other observations to management.
• Review batch records and related production documentation, resolving identified issues before product disposition.
• Collaborate with internal functions to address issues promptly.
• Disposition incoming raw materials.
• Apply quality compliance theories and principles to address issues independently.
• Provide guidance on controlled documents, identifying gaps, and suggesting process improvements.
• Maintain and report on Quality Metrics.
• Initiate and participate in SOP revisions to improve compliance.

Compensation:

• USD 30-40 per hour

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

º¬Ðß²ÝÓ°Ôº is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

º¬Ðß²ÝÓ°Ôº Staffing is an equal opportunity employer.