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Document Control Specialist - Berkeley Heights, United States - Vertellus
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:
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
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:
Bachelor's degree in a scientific discipline is required
Experience:
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
Knowledge, Skills, and Abilities:
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
If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you.
Apply todayAurorium 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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