Document and Record Control Specialist
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Buffalo Grove, IL 60089
Summary of Position:
Working under the direct supervision of the Quality Manager and senior Quality Assurance management, the Document and Record Control Specialist will be responsible for inspecting quality records for accuracy and compliance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs).
They will also be responsible for reviewing, editing and entering documents into the document vault to ensure all records and documents are accurate and the most current revision. In addition, they will store, manage and track company documents through approval steps as needed which includes scanning, imaging, organizing and maintaining documents, adhering to the company’s document lifecycle procedures, and they file records in accordance with the records retention schedule. They perform administrative tasks as needed.
The Document and Record Control Specialist will utilize their process knowledge, experience, and understanding of SOPs and cGMP to ensure control of the Quality Management System (QMS) documentation and record keeping requirements to ensure compliance to regulatory and company requirements
- Exhibits a thorough knowledge of the Document Management System processes and establishes and maintains strong local administration support.
- Coordinates the revision process of SOPs, forms and other controlled documents.
- Coordinates the review of QMS documents and confirms compliance to SOPs before routing for formal approvals.
- Coordinates the approval of QMS documentation in accordance with SOPs.
- Releases QMS documents in accordance with SOPs.
- Files electronic and hard copy records as directed and in accordance with the records retention schedule.
- Archives QMS documentation in accordance with SOPs
- Audits quality records for accuracy and compliance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs).
- Ensure any quality record errors are corrected, all quality record components are present, and exception documents are referenced and approved according to SOP requirements
- Provides guidance and/or coaching on documentation requirements and corrections
- May release quality records in electronic systems and update metric reports for trending
- Submit Change Requests as needed.
- Ensure quality records are retained and filed securely
- Perform any other tasks/duties as assigned by management.
- Organize and maintain department files and spreadsheets.
- Records and escalates exceptions to quality records as appropriate
- Highly motivated, self-directed with the ability to work independently and as a team member in a fast paced deadline oriented environment.
- Detail-oriented, dependable and trustworthy as you are working with complex and sensitive documents.
- Ability to prioritize, manage time well, multitask and troubleshoot. Strong interpersonal, communication and customer service skills.
- Computer-savvy and well-versed in Microsoft Office products.
- Experience with document control software.
- Knowledge of document management processes.
- Experience in an FDA cGMP Quality Management System required.
- Ability to collaborate with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. Extract information and grasp complex technical concepts through research, interviews, hands on product testing, training, and other methods, to prepare accurate, complete documentation.
- Ability to collect, organize and clarify technical information in a clear and logical manner and the ability to work on several projects simultaneously
- Experience with Adobe Acrobat, Visio and other graphics applications preferred.
- Solid understanding of accurate reporting and documentation within the manufacturing process and can support the strategic and operational objectives of the business.
- Possess a high degree of professionalism, maturity and confidentiality.
- Ability to deal with stressful situations as they arise.
- Must be a highly flexible individual who can work well in an environment with defined production deadlines
- Ability to be flexible in covering manufacturing shift hours
- Must be available to work overtime, including weekends, as needed
- Ability to take feedback constructively and function in a team-oriented work environment.
- Good interpersonal relations/communication skills
Education and Experience:
- High School Diploma or GED, with emphasis on business communications and office practices
- 2 – 5 years related work experience as a Record Control Specialist (e.g. Batch Records) in a regulated environment.
- 3 to 5 years’ experience as a Document and Record Control Specialist with strong written and oral communication, and interpersonal skills.
Please note that candidates need to be eligible to work in the U.S. now and in the future without ARxIUM sponsorship for an employment-based visa.
ARxIUM is an Equal Opportunity Employer – Disability and veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status or other characteristics protected by law.
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E-Verify EEO is the Law Poster Supplement ARxIUM Policy on EEO Pay Transparency Nondiscrimination Provision Right to work statement
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
ARxIUM is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status or other characteristics protected by law.