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Quality Operations Specialist II (Night shift)
300 Rouse Blvd. Philadelphia, PA 19112 US
Job Description
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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