- Specification (OOS) Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations Proficiency with Microsoft Office Excellent verbal and written communication and skillsAbility to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team membersAnalytical thinking with excellent problem solving skills and the ability to adapt to changing priorities and deadlinesExcellent planning, organization and time management skills including the ability to support and prioritize multiple projectsFluent in English (verbal and written)Ability to identify and distinguish colorsSpecial knowledge or skills needed and/or licenses or certificates preferred Certified Quality Manager, Engineer or AuditorExperience with drug device combination products (highly desirable)Travel requirements0%Physical requirementsOffice based position Tris Pharma, Inc.
-
BlueWave Solutions Princeton, United StatesAbout the Company · We offer consulting and IT services for all commercial areas of business, individual programming, as well as server and network technology for medium-sized companies. · What do we offer? · 31 vacation days · A relaxed and dynamic team, combined with a flat hie ...
-
Manager, Quality Management Systems
3 weeks ago
Tris Pharma Monmouth Junction, United States Full timeTris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have ma ...
-
Financial Aid System Manager
1 week ago
Wilson College Chambersburg, United States**ESSENTIAL FUNCTIONS**: · - Serve as the functional area lead and liaison to Information Technology related to financial aid and communication modules in Ellucian Colleague. · - Collaborate with staff in other functional areas/offices to ensure effective data integration and sys ...
-
Phoenix Industries Brunswick, United StatesAbout the Company · Our company represents an innovative, modern, medium-sized, owner-managed, yet traditional group of companies in the field of FREIGHT, LOGISTICS, and SOLUTIONS. · Innovative ideas, flexibility, and investment readiness as a sustainable corporate concept are th ...
-
System Analyst, Warehouse Management
2 weeks ago
G-III Apparel Dayton, United StatesGIII Apparel Group is a leading manufacturer and distributor of apparel and accessories under licensed brands, owned brands and private label brands with an entrepreneurial culture that flows throughout the comprehensive portfolio of over 30 licensed and proprietary brands, inclu ...
-
Online Database management system tutor
2 weeks ago
TeacherOn Edison, United States Part timeData base management sysyems · Level: Expert · Gender Preference: None · Meeting options: · Available online - via skype etc. ...
-
Manager, Distribution Systems
2 weeks ago
Crate&Barrel Cranbury, United StatesMaximize company sales growth and profitability by assisting the Distribution Center to manage daily operations, system performance, release management, quality of associate work, and inventory management. Focus on promoting sales as they pertain to or are driven by your position ...
-
Maintenance & Facility Mgr
1 week ago
L'Oreal Monmouth Junction, United States**Job Title**:Maintenance & Facility Manager** · **Division**:Luxe Division** · **Location**:Monmouth Junction** · **Reports To**:Innovation & Engineering Sr. Manager** · **Who We Are**: · For more than a century, L'Oréal has devoted its energy, innovation, and scientific excelle ...
-
Supervisor, Field Service
1 week ago
Liberty Coca-Cola Bev LLC Monmouth Junction, United States**About Liberty**: · At Liberty Coca-Cola, we strive to make our workforce as inclusive and diverse as the communities we serve. Our associates are our #1 asset, and we are committed to investing in our people, maintaining the highest safety standards, and creating a culture of g ...
-
Training & Placement for Business Analyst
1 week ago
Precision Techserve Pvt. Ltd Monmouth Junction, United StatesHello · Any Business Analyst here please reach me out, we have good opportunities for you.. · No C2C only W2 · We are currently seeking a skilled and dedicated Business Analyst to join our team. · Education Qualification: MS/BS:CS,IT,IS. · Exp:6-14years · **Business Analyst Job D ...
-
Skyline Enterprises Monmouth Junction, United StatesThe Chamber of Agriculture Rhineland-Palatinate - public corporation - is looking for a(n) Employee (m/f/d) for the "Online Service Viticulture" department at the earliest possible date in Monmouth Junction. · Employee (m/f/d) for the "Online Service Viticulture" department · The ...
-
Genmab Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Logistics Coordinator
3 days ago
Hermann Services Monmouth Junction, United States**Job Term**: Full Time · **Full Job Description**: · **Hermann Services is looking for a Logistics Coordinator to join our office in Monmouth Junction, NJ.** · The Logistics Coordinator will be responsible for brokering truckloads and containers to outsourced carrier partners, n ...
-
Manager, Financial Systems
3 weeks ago
Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Scientific employee in
4 days ago
Oceanic Ventures Heathcote, NJ, United States Freelance**Scientific Employee (m/f/d) - Education Development Plan/Education Monitoring**: · **(Salary group 13 TVöD; minimum 50,249; · - € to 73,074; · - € per year, depending on relevant professional experience) · to be filled at the Office for Children, Youth, Schools and Integration ...
-
Front Office Supervisor
4 days ago
ZephyrTech Heathcote, NJ, United States Freelance**Company Description** Our heart beats turquoise. · Working at Motel One is like coming to friends, where appreciation and support are valued and individual personality is welcome. We treat each other as equals and see ourselves as a team: from management to apprentices. · With ...
-
Working student
4 days ago
Orion Innovations Heathcote, NJ, United States Freelance**PAYBACK** is globally unique in data-driven marketing. With the ability to develop digital business models and implement technical trends, we are pioneers in the data economy. All technical solutions for the PAYBACK program are invented and realized in Munich. We work cross-fun ...
-
Warehouse Specialist
4 days ago
Golden Gate Group Heathcote, NJ, United States FreelanceWarehouse Specialist (m/f/d) in Heathcote, NJ · Various awards and certificates from renowned institutions, including Great Place to Work, Audit Beruf und Familie, and the German Quality Award, attest to our workplace and service quality. · We are looking for a qualified speciali ...
-
Manager, Financial Systems
3 weeks ago
Genmab Princeton, United States Full timeThe Role · We are seeking a highly skilled and experienced SAP Change Management Expert to join our Finance SAP Center Of Excellence (CoE). This role involves working closely with SAP Business Champions and end-users to ensure smooth transitions, effective user adoption, and opti ...
-
Omega Innovations Feasterville, United StatesHeinrich Heine University - IT System Administrator for Campus Management and Administrative Applications · The Heinrich Heine University Düsseldorf (HHU) is seeking a IT System Administrator for the Center for Information and Media Technology (ZIM) in the area of campus manageme ...
Manager, Quality Management Systems - Monmouth Junction, United States - Tris Pharma
Description
Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs.We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation.
Tris colleagues understand the criticality of operating a successful business and take pride in the company's success.But of equal importance to each member of the team is how we interact with one another on a daily basis.
We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS).Summary:
The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA)
Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.
investigations, deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc
Responsibilities:
Assures compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)
Works directly and cross functionally throughout company (i.e., QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.)
investigative processes, CAPAs and CPIs, etc.
Participates in regulatory agency inspections and customer audits, as needed; Performs and/or participates in internal and external audits, as neededManages, coaches and mentors direct reportsAny other assignments determined by the management RequirementsMinimum education and years of relevant work experience:
Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses or certificates required People management experience Strong hands-on knowledge of cGMPs in the pharmaceutical industry and application of current Good Documentation Practices (cGDPs) within pharmaceutical industryExperience implementing and managing quality systems and processesFamiliar with US FDA guidance and other international guidelines on Investigating Out-of