- 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
- 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
- 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
- BS degree in Chemistry or Engineering with a MS preferred
- 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
- 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
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Quality Manager - Berkeley Heights, United States - Aurorium LLC
Description
Job Description
Job DescriptionCompany 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:
Compliance:
Problem Solving and Innovation:
Qualifications/Desired Skills:
Education and Qualifications:
Experience:
Knowledge, Skills, and Abilities:
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.
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