Job Description:
· ARM Group LLC is actively hiring for a "Document Control Specialist" with one of our clients in Chicago, IL
Department:
· Quality Assurance
Manager:
· Quality Assurance Manager
Job Title:
· Document Control Specialist
General Overview:
· The Document Control Specialist is responsible for issuing, maintaining, communicating, controlling, and auditing documentation to support the plant quality systems for cGMP compliance. This includes maintaining the site-wide documentation control system, and liaison with the customer documentation system.
Key Responsibilities:
· Issue, maintain, communicate, control, and audit documentation associated with:
· Standard Operating Procedures & Associated Documents
· Manufacturing procedures, Process procedures, Laboratory procedures, General procedures
· Master formulas and Batch sheets/cards
· Master & Batch Production Records & Associated Documents
· Raw Material and Packaging Purchasing Specs
· Liaison with customer documentation systems to provide change control and compliance with customer standards and requirements.
· Responsible for maintaining and updating the site-wide Documentation Control Index and database system.
· Responsible for maintaining and updating the data files, controlled documents, master binders, and equipment stored in the “Quality Library”.
· Ensure production forms are current and available for use on the production floor.
· Conduct cGMP training for the facility.
· Support the approval of incoming packaging material receipts for production.
· Support the documentation of technical/manufacturing reviews, continuous improvement reviews, and internal/external audits.
· Maintain the quarterly consumer complaint reports.
· Provide support to backfill other Quality roles as needed.
· Adhere to all safety policies and procedures.
· Maintain the LIMS.
Qualifications:
· Basic Minimum Requirements
· Meet the legal minimum age requirement.
· Authorized to work in the United States
· Bachelor’s degree in a science/business-related field (or equivalent combination of education and experience).
· Knowledgeable of the cGMP regulations and standards
· Intermediate skills in Microsoft Office (Outlook, Word, Excel, PowerPoint)
· Ability to work overtime as needed.
Other Required Skills:
· Ability to maintain accurate and detailed records.
· Ability to work independently and as part of a team.
· Strong organizational and interpersonal skills
· Strong planning and organizing skills.
· Strong verbal and written communication skills
Preferred Qualifications:
· Bachelor’s Degree in a relevant field of study
· Experience in managing document control systems.
· Advanced skills in Microsoft Office (Outlook, Word, Excel, Power Point)
· Experience in performing analytical testing in a lab environment.
Physical Requirements:
· Ability to sit for long periods working in front of a computer screen.
· Ability to lift up to 25 lbs. occasionally.
· Ability to stoop, bend, twist occasionally.
ARM GROUP is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.
ARM GROUP welcomes and encourages applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States.
This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Job Type: Full-time
Pay: $40,000.00 - $55,000.00 per year
Benefits:
Schedule:
Application Question(s):
Education:
Experience:
Work Location: In person