- Provides ongoing support and review of Quality System documents including SOPs, Work Instructions, and other functional documentation to ensure adherence to industry standards including cGMP, FDA and other applicable quality standards, regulations, and corporate policies
- Reviews batch records for accuracy and releases for next steps
- Manages quality department documentation in Master Control
- Writes, formats, and edits documents, including Standard Operating Procedures, Forms, and policies to support site operations
- Works closely with personnel from surrounding functional groups to investigate and document Out of Specification results, Process Deviations, and Corrective and Preventive Actions (CAPA)
- Coordinates efforts to ensure root cause analysis, actions, closure of investigations, and verification of effectiveness of solutions are properly applied to issues originating from atypical events and from quality audits
- Provides training to support quality system and documentation practices as needed and/or requested. Administers and maintains training records
- Perform on-boarding Quality training of new hires
- Reviews and/or completes Laboratory Certificate of Analyses for customer shipments
- Responsible for the organization and management of all Production Lot files maintained by the Quality Department for manufactured products
- Conducts quality checks of shipments prior to being loaded onto trucks
- Monitors external regulations to help ensure site compliance
- Maintains healthy relations with cross-functional departments to solicit information and assistance when necessary
- Participates in internal and external audits
- Performs other duties and completes special projects 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
- Bachelor's degree in a scientific discipline is required
- 5+ years of Quality Control/Quality Assurance/Document Control experience in a manufacturing plant is preferred; pharmaceutical manufacturing experience is a plus
- Experience with document control and records management
- Experience using Master Control for document management is preferred
- 5+ years' experience in a cGMP regulated environment is preferred
- Knowledge of regulatory requirements for active bulk pharmaceuticals (API) is a plus
- Experience with SAP preferred
- Problem solving skills including the ability to analyze technical data and make creative and balanced decisions
- Self-motivated and ability to work within a fast-paced environment
- Excellent written and verbal communication skills with the ability to flex own style as needed to influence and drive results
- Demonstrated high technical aptitude as well as analytical skills
- Strong organizational skills and attention to detail with the ability to adapt quickly to changing business needs and priorities
- Ability to work in a team environment within a multi-functional, organizational structure and exhibit robust interpersonal skills
- Excellent proficiency within Microsoft products (Outlook, Excel, Word, PowerPoint)
- Critical thinking and conflict resolution skills and analytical abilities which allow assessment of customer service issues, situations, and opportunities
- 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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Description
Company OverviewAurorium 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:
The Document Control Specialist is responsible for ensuring that all site documentation is in compliance with all relevant quality system and regulatory requirements. This includes review of production records for product release, work instructions including SOPs, training records, and other applicable quality standards, regulations, and corporate policies. In addition, this position investigates and corrects quality issues, reviews and releases batch records, and promotes continual improvement in quality control and assurance areas.
Responsibilities:
Role Specific Responsibilities:
Education and Qualifications:
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
