Document Control Specialist

1 month ago

Berkeley Heights, United States Vertellus Full time

Vacancy Name Document Control Specialist
Vacancy No VN166
Department Quality
Location Berkeley Heights
Employment Type Full-Time
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 healthcare, personal & home care, mobility, infrastructure, 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.
Description 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.
Job Details 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 MasterControl
  • 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
Knowledge, Skills, and Abilities:
  • 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 MasterControl 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 standard.

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.#LI-Onsite

Status Active

  • Document Control Specialist Role in Pharmaceutical Manufacturing

    3 weeks ago

    Berkeley Heights, New Jersey, United States Vertellus Full time

    About the RoleWe are seeking a highly skilled Document Control Specialist to join our team at Aurorium, a global materials innovation partner. This role is responsible for ensuring that all site documentation meets regulatory requirements and adheres to industry standards.Key ResponsibilitiesProvide ongoing support and review of Quality System documents,...

  • Document Control Specialist

    3 months ago

    Chicago Heights, United States Hargrove Engineers & Constructors Full time

    Hargrove is seeking a Document Control Specialist to join our team onsite in Chicago Heights, IL. What You'll Be DoingJob Scope: Generally responsible for document management for projects and personnel. This work will be performed under general supervision. Primary responsibilities will include but are not limited to:Document management of electronic files...

  • Document Control Specialist

    2 months ago

    chicago heights, United States Hargrove Engineers & Constructors Full time

    Hargrove is seeking a Document Control Specialist to join our team onsite in Chicago Heights, IL. What You'll Be DoingJob Scope: Generally responsible for document management for projects and personnel. This work will be performed under general supervision. Primary responsibilities will include but are not limited to:Document management of electronic files...

  • Document Control Specialist

    3 months ago

    chicago heights, United States Hargrove Engineers & Constructors Full time

    Hargrove is seeking a Document Control Specialist to join our team onsite in Chicago Heights, IL. What You'll Be DoingJob Scope: Generally responsible for document management for projects and personnel. This work will be performed under general supervision. Primary responsibilities will include but are not limited to:Document management of electronic files...

  • Quality Assurance Document Specialist

    3 weeks ago

    Berkeley Heights, New Jersey, United States Vertellus Full time

    About the Role:We are seeking a skilled Quality Assurance Document Specialist to join our team at Vertellus.Job Description:This role is responsible for ensuring that all site documentation is in compliance with relevant quality system and regulatory requirements. This includes reviewing production records for product release, work instructions, training...

  • Document Control Specialist

    1 month ago

    Chicago Heights, United States Hargrove Engineers & Constructors Full time

    Who We Are Hargrove supplies unparalleled services in engineering, procurement, construction management, and technical services in the industrial, commercial, and government sectors. With over 2,000 Teammates across the US, we build long-term support relationships in the energy generation, manufacturing, research and development, and process-heavy industry...

  • Quality Control Specialist

    13 hours ago

    Berkeley, California, United States Randstad Life Sciences Full time

    About the RoleWe are looking for a skilled Quality Control Specialist to join our team. In this role, you will be responsible for performing routine release testing of raw materials and drug products.The ideal candidate will have a strong background in wet chemistry and experience working with simple instruments such as pH, conductivity, TOC, and...

  • Customer Service Sales Representative: Motion

    3 weeks ago

    Sterling Heights, Michigan, United States Motion & Control Enterprises Full time

    Job Description:Motion & Control Enterprises is seeking a highly motivated and organized Inside Sales Specialist to join our team. As an Inside Sales Specialist, you will play a critical role in executing customer orders and quote requests, providing exceptional customer service, and driving sales growth.About the Role:We are looking for a detail-oriented...

  • Process Controls Specialist

    1 week ago

    Sterling Heights, Michigan, United States CyberCoders Full time

    Job Description:We are seeking a skilled Process Controls Specialist to join our team at CyberCoders. In this role, you will be responsible for designing and implementing control systems for various industrial processes.Main Responsibilities:Design and implement control systemsDevelop and maintain HMI and PLC programsCollaborate with engineering teamsConduct...

  • Controller

    2 weeks ago

    Berkeley, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are offering an exciting opportunity for a Controller in Berkeley, California. In this role, you will be tasked with utilizing various accounting software systems, managing financial services, and maintaining customer relations. Your primary responsibilities include overseeing accounting functions, ensuring the accuracy of...

  • Food Service Quality Control Specialist

    5 days ago

    Berkeley, California, United States Levy Full time

    Job OverviewWe are seeking a skilled Food Service Quality Control Specialist to join our team at Levy. This role is responsible for ensuring top-notch products and services in our food service operations.Key Responsibilities:Conduct regular inspections to maintain quality standards.Collaborate with staff to address any issues or concerns.Develop and...

  • Electrical Systems Specialist

    22 hours ago

    Arlington Heights, Illinois, United States Master Control Systems, Inc. Full time

    Job Title:Electrical Systems SpecialistDescription:We are seeking a skilled and experienced Electrical Systems Specialist to join our team at Master Control Systems, Inc.Responsibilities:Travel to client sites to perform startup and maintenance on industrial controllers up to 600 voltsPerform tests and diagnostics to ensure equipment is in good working...

  • Process Controls Specialist

    7 days ago

    Sterling Heights, Michigan, United States ManpowerGroup Full time

    We are seeking a highly skilled Process Controls Specialist to join our team in Sterling Heights, MI. The ideal candidate will have a strong understanding of process control systems and the ability to design and implement effective solutions.The estimated salary for this position is $47/hour, dependent on experience level.Job Description:The Process Controls...

  • Pest Control Specialist

    7 days ago

    Peoria Heights, Illinois, United States Quik-Kill Pest Eliminators Inc Full time

    Pest Control Specialist Role OverviewWe are seeking a skilled Pest Control Specialist to join our team at Quik-Kill Pest Eliminators Inc. As a valued member of our organization, you will play a crucial role in ensuring the comfort and safety of our community by providing top-notch pest control services.In this position, you will be responsible for visiting...

  • Senior Electrical Engineer

    3 weeks ago

    Richmond Heights, Virginia, United States AMF Bakery Full time

    About the RoleWe are seeking an experienced Senior Electrical Engineer to join our team as a Control Systems Specialist at AMF Bakery System's headquarters.Job Summary:The successful candidate will be responsible for designing and developing electrical control systems, hardware, and software for our products. This includes current standard machines/systems,...

  • Clinical Documentation Improvement Specialist

    7 days ago

    Richmond Heights, Virginia, United States UHS Full time

    Company OverviewUniversal Health Services, Inc. (UHS) is a leading provider of hospital and healthcare services in the United States. With a strong presence across the country, UHS operates acute care hospitals, behavioral health facilities, outpatient facilities, and ambulatory care access points.Salary and BenefitsThe estimated annual salary for this role...

  • Knowledge Management and Documentation Specialist

    1 week ago

    Sterling Heights, Michigan, United States Peraton Full time

    Peraton is seeking a knowledgeable IT Support Specialist to join our team as a Technical Writer. In this role, you will be responsible for creating high-quality documentation that supports the success of our service desk analysts. With a strong background in technical writing and experience using ServiceNow, you will ensure that our knowledge base is...

  • Clinical Documentation Specialist

    3 weeks ago

    Richmond Heights, Virginia, United States UHS Full time

    Job OverviewWe are seeking a skilled Clinical Documentation Specialist to join our team in acute care. The successful candidate will be responsible for reviewing medical records to ensure accurate and compliant documentation.

  • Inventory Control Specialist

    3 weeks ago

    Warminster Heights, Pennsylvania, United States Burpee Full time

    At Burpee, we're passionate about quality and innovation in home gardening. We're seeking a highly motivated individual to join our team as an Inventory Control Specialist.**Estimated Salary:** $65,000 - $80,000 per yearAbout the RoleThis is a key position that supports the day-to-day inventory level accuracy by analyzing data and performing corrective...

  • Material Control Specialist

    1 week ago

    Sterling Heights, Michigan, United States Volt Workforce Solution Full time

    Job Title: Material Control SpecialistSalary: $18 - $20 per hourWe are seeking a highly skilled Material Control Specialist to join our team at Volt Workforce Solution in Sterling, VA.About the Job:This is a Full Time, Contract opportunity that will last for 6+ months.The candidate shall be responsible for performing a wide array of warehouse jobs, including...