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Quality Manager - Berkeley Heights, United States - Aurorium LLC
Description
Job DescriptionJob Description
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.
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:
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