Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.propharmagroup.com
https://www.propharmagroup.com
true
Target Pay Rate: 35-46.74/hr **salary will be commensurate with experienceÂ
Job Description:
Primary Activities may include, but are not limited to the following:
• Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer.
• Support routine and complex change requests and support process modification change controls.
• Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
• Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed.
• Gather, interpret, and report, in a timely manner data for internal Annual Product Review (when required).
• Participate with site visits to build relationships and monitor efforts to improve the external manufacturers quality and reliability through ongoing oversight and formal communication programs and forums.
• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME)
Â
Qualifications:
• Education: BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 5 years of relevant experience within Quality Systems, Quality Assurance, and Quality Control. • Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes. • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills. • Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc. Required Skills: • Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements. • Must be able to handle multiple priorities at a time and immediately address urgent issues. • Solves complex problems; takes a new perspective using existing solutions. • Accountable for medium sized projects with minimal resource requirements, risk and/or complexity. • Works independently, receives minimal guidance. • Experience with administration and data entry of technical reports into internal databases. • Explains difficult issues and works to build alignment around a complex situation. • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. • Strong knowledge of External Manufacturing management, supply chain, and operations. • Communicates easily in English both verbally and in writing. • Lean Six Sigma Systems training is an advantage. • Fluent in English language (reading, writing, and speaking) Softwares: • Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Trackwise Change Control (GCM).
Senior Specialist Quality Assurance - Level III (Senior)
30 Hudson Street Jersey City, NJ 07302 US
Posted: 08/14/2024
2024-08-14
2024-11-12
Employment Type:
Contract
Job Category: QA/Automation
Job Number: 612938
Is job remote?: Yes
Country: United States
Job Description
Target Pay Rate: 35-46.74/hr **salary will be commensurate with experienceÂ
Job Description:
Primary Activities may include, but are not limited to the following:
• Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer.
• Support routine and complex change requests and support process modification change controls.
• Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
• Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed.
• Gather, interpret, and report, in a timely manner data for internal Annual Product Review (when required).
• Participate with site visits to build relationships and monitor efforts to improve the external manufacturers quality and reliability through ongoing oversight and formal communication programs and forums.
• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME)
Â
Qualifications:
• Education: BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 5 years of relevant experience within Quality Systems, Quality Assurance, and Quality Control. • Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes. • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills. • Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc. Required Skills: • Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements. • Must be able to handle multiple priorities at a time and immediately address urgent issues. • Solves complex problems; takes a new perspective using existing solutions. • Accountable for medium sized projects with minimal resource requirements, risk and/or complexity. • Works independently, receives minimal guidance. • Experience with administration and data entry of technical reports into internal databases. • Explains difficult issues and works to build alignment around a complex situation. • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. • Strong knowledge of External Manufacturing management, supply chain, and operations. • Communicates easily in English both verbally and in writing. • Lean Six Sigma Systems training is an advantage. • Fluent in English language (reading, writing, and speaking) Softwares: • Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Trackwise Change Control (GCM).
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Jersey City, NJ
Ready to take the next step in your career? Explore our job opportunities in and around Jersey City, New Jersey, where the vibrant cityscape meets the calming waters of the Hudson River. This dynamic area offers a perfect blend of urban living and green spaces, with easy access to New York City just a short ride away. Imagine working in the shadow of the iconic Statue of Liberty, enjoying diverse cuisine from food trucks to Michelin-starred restaurants, or catching a show at the historic Loew's Jersey Theatre. Jersey City boasts an impressive art scene, lively nightlife, and plenty of outdoor recreational options at Liberty State Park. Join us in this culturally rich and fast-growing region, and make your career dreams a reality!
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.
