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Quality Operations Specialist II (Night shift)

Philadelphia, PA 19112

Posted: 12/06/2024 Employment Type: Contract To Hire Job Category: Quality and Compliance Job Number: 614664 Is job remote?: No Country: United States

Job Description

Overview

We are seeking highly motivated Quality Operations Specialist II to join the facility’s Quality Operations team. The Quality Operations team will be responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures. The Specialist, Quality Operations, will work alongside manufacturing personnel, helping to ensure that the highest standard of work is performed.

Shifts: 
•    Wednesday to Saturday 7pm - 6am
•    Sunday to Wednesday 7pm - 6am 

Essential Functions and Responsibilities

•    Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
•    Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
•    Disposition incoming raw materials
•    Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
•    Maintain and report on Quality Metrics.
•    Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Maintain and report on Quality Metrics.
•    Other tasks as assigned.

Basic Qualifications

•    A Bachelor’s Degree in Science, Engineering, or a related technical discipline or equivalent industry experience.
•    At least: 3+ years’ experience in a regulated industry.
•    Working knowledge of cGMP regulations.
•    Prior experience and ability to work in an aseptic processing environment.
•    Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
•    Attention to detail.
•    Knowledge of QMS systems is a plus.

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Philadelphia, PA

Ready to embark on a new career adventure in the vibrant city of Philadelphia, Pennsylvania? Explore our job opportunities in the City of Brotherly Love and discover the countless growth possibilities this historic region offers aspiring professionals. From iconic landmarks like the Liberty Bell and Independence Hall to the mouthwatering Philly cheesesteaks and world-class art galleries such as The Barnes Foundation, Philadelphia is a treasure trove of culture and charm. With renowned theaters like the Walnut Street Theatre, professional sports teams like the Eagles and Phillies, and gorgeous outdoor spaces like Fairmount Park, Philadelphia has something for everyone. Don't miss out on the chance to make your mark in this dynamic city — browse our job listings now and take the first step towards your dream career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.