We have other current jobs related to this field that you can find below
-
Quality Assurance Manager
2 months ago
Berkeley Heights, United States Breckenridge Pharmaceutical Full timeBreckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.This position reports to the Associate Vice President, Quality Assurance and will manage or...
-
Quality Assurance Manager
3 months ago
Berkeley Heights, United States Breckenridge Pharmaceutical, Inc. Full timeBreckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.This position reports to the Associate Vice President, Quality Assurance and will manage or...
-
Manager Quality Assurance
3 months ago
Berkeley Heights, United States Breckenridge Pharmaceutical Inc Full timeJob DescriptionJob DescriptionBreckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.This position reports to the Associate Vice President, Quality...
-
Quality Management Intern
1 week ago
Berkeley Township, United States Bright Harbor Healthcare Full timeJob DescriptionJob DescriptionWe are seeking a dedicated and detail-oriented Quality Management Intern with a focus on data analytics to join our team.As a Quality Management Intern specializing in data analytics, you will play a crucial role in ensuring the efficiency and accuracy of our systems and processes. This internship offers a unique opportunity to...
-
Quality Management Intern
4 months ago
Berkeley Township, United States Bright Harbor Healthcare Full timeJob DescriptionJob DescriptionWe are seeking a dedicated and detail-oriented Quality Management Intern with a focus on data analytics to join our team.As a Quality Management Intern specializing in data analytics, you will play a crucial role in ensuring the efficiency and accuracy of our systems and processes. This internship offers a unique opportunity to...
-
Quality Engineer
3 weeks ago
Berkeley, United States Global Channel Management Full timeQuality Engineer needs 3+ years of Quality experience in a manufacturing environment is a plus Quality Engineer requires: Bachelor's Degree in Engineering field preferred but not required • 3+ years of Quality experience in a manufacturing environment is a plus • Understanding of ISO 9100, ISO 45001 and TS16949 requirements • Problem solving skills...
-
Project Manager
1 month ago
Madison Heights, United States Stratosphere Quality Full timeJob DescriptionJob DescriptionOverviewProject ManagerThe Project Manager serves as a key leader, this position has responsibilities for the Operation and Logistical management of the defined area.Accountable for the quality of our projects and productivity of our teams throughout the assigned regions.Salary: $50-$60K Shift Requirements:...
-
Quality Manager
1 week ago
Chicago Heights, United States PeopleShare Inc Full timePeopleShare is hiring for a direct hire opportunity and is looking for seasoned professionals who have a passion for Quality Assurance. Our client is a custom steel fabrication and precision machining shop that has been in business for more than 50 years. They have a unique product line, specializing in the railroad industry. Apply now for immediate...
-
Quality Manager
3 weeks ago
Maryland Heights, United States Refresco Full timeMake a Difference in YOUR Career! Our vision is both simple and ambitious: to put our drinks on every table. We are the leading global independent beverage solutions provider. We serve a broad range of national and international retailers as well as Global, National and Emerging (GNE) brands. Our products are distributed worldwide from our production...
-
Quality Manager
16 hours ago
Glendale Heights, United States Labor Solutions, LLC Full timeJob DescriptionJob DescriptionYour Journey with Spices Begins Here! If you envision a future where your love for spices intersects with a rewarding career in a dynamic and supportive environment, we want you in the U.S. Spice Mills family. Together, let's blend passion, hard work, and excellence to create the perfect recipe for success.Apply now and...
-
Service Manager
3 months ago
Berkeley Heights, United States Tata Consultancy Services Full timeTechnical/Functional Skills We are seeking a talented and experienced Incident cum MI manager to join our team. The person will be responsible for managing operations for a support team (with onpremise and Azure presence). This is a challenging role that requires a strong understanding of how services are being run and measured and is the critical link...
-
Manager/ Senior Manager
2 months ago
Berkeley Heights, United States Axtria, Inc. Full timeJob DescriptionJob DescriptionAxtria IntroductionAxtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead...
-
Manager/ Senior Manager
4 weeks ago
Berkeley Heights, United States Axtria, Inc. Full timeJob DescriptionJob DescriptionAxtria IntroductionAxtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead...
-
Dispensary Assistant General Manager
3 months ago
Madison Heights, United States Quality Roots Full timeJob DescriptionJob DescriptionFull Job DescriptionCompany Description:Quality Roots is the premier retail company serving Michigans' recreational cannabis community. We represent a team of highly experienced, knowledgeable professionals who have a long history of owning and operating local, family-owned businesses within the state of Michigan.Through our...
-
Technical Project Manager/Java
2 months ago
Berkeley Heights, New Jersey, United States Cognizant Full timeTechnical Project Manager/Java (On-site) Cognizant's Digital Engineering Our practice is seeking a highly qualified Technical Project Manager with experience developing and building impactful, scalable, enterprise applications. Our Developers have a passion for high-quality, reliable, and maintainable code. You will work side by side with product managers,...
-
Senior Managers and Industrial Engineer
2 months ago
Berkeley Heights, United States Axtria Full timeSenior Managers and Industrial Engineer - Axtria Inc - Berkeley Heights, NJ Berkeley Heights, NJ Sr. Manager: Elicit rqmnts by conducting evaluations of Axtria's pharma clients' business needs & translate business rqmnts into technical rqmnts to provide strategic software systems solutions. Collaborate w/team members for project execution & ongoing support...
-
Manager, Quality Assurance
3 weeks ago
Glendale Heights, United States Clyde's Donuts Full timeWho We AreFounded in 1920 and based in Addison, Illinois, Clyde’s is a thriving, 4th generation family-owned food manufacturer and a leading national supplier of donuts to the largest global retailers in mass grocery, convenience stores, and food service. We specialize in the manufacture of a wide assortment of ready to serve, ready to sell, and ready to...
-
Quality Assurance Manager
22 hours ago
Arlington Heights, United States SIPS Consults Full timeJob DescriptionJob DescriptionJob SummaryThe CSPD Quality Assurance Interim Manager (QA Manager) will conduct and oversee day-to-day operations needed for successful capture of field issues and reliability testing. This includes but is not limited to receipt, test, analysis, and reporting. The manager shall be able to proficiently oversee an average of 30...
-
Regulatory Affairs Manager
4 weeks ago
Berkeley Heights, United States Breckenridge Pharmaceutical Full timeBreckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.JOB SUMMARY:The Regulatory Affairs Manager will be responsible for independently compiling...
-
Manager Regulatory Affairs
3 weeks ago
Berkeley Heights, United States Breckenridge Pharmaceutical Inc Full timeJob DescriptionJob DescriptionBreckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.JOB SUMMARY:The Regulatory Affairs Manager will be responsible...
Quality Manager
3 months ago
Company Overview
Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions. Key industries served include household products, coatings & adhesives, energy & electronics, healthcare, food & beverages, agriculture, transportation, and paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities. The company’s global integrated supply chain offers the customer product consistency, easy access, supply security and reasonable turnaround on delivery. Aurorium is committed to operating at the highest levels of manufacturing consistency, quality control and safety.
Job Summary:
Manages the overall Quality function for the facility. Responsible for maintenance of all regulatory licenses and documentation; including Drug Master File (DMF), Certificate of Suitability (CEP) and on-site Standard Operating Procedures (SOPs). Responsibilities include maintaining plant wide conformance to excipient and Pre-requisite Programs, FDA/cGMP/ICH regulations. Coordinates, investigates, and documents all nonconformances including customer complaints. Manages all regulatory and customer audits and inquiries.
Responsibilities:
Role Specific Responsibilities:
- Has responsibility and authority to oversee the development, implementation, review, maintenance, and management of the on-site Quality program for the
- facility .
- Approves all plant procedures and any changes that may affect the Quality of the product
- Develops and implements new and/or improved programs to assure continual Quality improvements
- Leads the investigation of all customer complaints/dissatisfactions and provides written documentation as required
- Ensures efficient and safe operations of the lab
- Works closely with the Quality Laboratory Supervisor to oversee and coordinate daily workload to ensure timely release of finished goods
- Manages/coordinates flow of documentation from Production depts. to Quality dept. to ensure timely review of documents
- Trends data and reports potential problems to Management. Approves the Stability Program and Annual Product Review for the facility
- Maintains SOPs and Forms on the Aurorium DMS Document Management System.
- Maintains all regulatory documents and forms including licenses, DMF, CEP and site SOPs and EXCIPIENT plans
- Maintains the MOC Management of Change, OOS Out of Specification, Deviation and CAPA Corrective and Preventive Action programs
- Manages and facilitates all compliance activities for ISO, cGMP, etc. and provides training programs workload to ensure timely release of finished goods
- Manages and conducts plant-wide cGMP training to assure compliance with all regulations
- Coordinates all on-site regulatory and customer audits and provides written responses as necessary in a timely fashion
- Responsible for auditing of both contract laboratories and processors including evaluation of proposed new and alternate raw material suppliers.
- Manages the Quality department budget (not including salaries), through direct involvement and management of Quality Control and Quality Assurance personnel
- Performs other duties as assigned
Compliance:
- Complies with company Health, Safety and Environmental policies, procedures, and arrangements
- Reports all Health, Safety and Environmental accidents, incidents and near misses promptly
- Acts in a safe and responsible manner at all times
Problem Solving and Innovation:
- Active participation in continuous improvement activities
- Participates in problem-solving
- Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
- Assists in the training, mentoring, and assessment of other team members
- Exercises autonomy and judgement subject to overall direction or guidance
Qualifications/Desired Skills:
Education and Qualifications:
- BS degree in Chemistry or Engineering with a MS preferred
Experience:
- Experience in a manufacturing environment.
- Minimum of five years’ experience in a Food and/or pharmaceutical manufacturing environment with a working knowledge of cGMP’s related to excipient manufacturing
Knowledge, Skills, and Abilities:
- Ability to solve practical problems and deal with a variety of changing situations.
- Strong time management and prioritization skills
- Working knowledge of regulatory requirements for active bulk pharmaceuticals (API)
- Computer literate: MS Word, Excel, Access, PowerPoint; SAP experience preferred
- Technical/Professional Knowledge and Skills analysis
- Embodies the core values of Aurorium:
- credible: keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions
- outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact
- driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness
- empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standards
If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. Apply today
Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays.
Aurorium is a global Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on gender, sexual orientation, gender identity, race, ethnicity, religion, age, veteran status, disability status, genetic information, or any other protected category.
Onsite: #LI-Onsite