Job Title: Documentation Specialist Job Description: The Documentation Specialist is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements. Additionally, this role supports the Business Management System by ensuring production is supplied with accurate labels and documentation required to fill products in a timely fashion. Responsibilities: + Process deviations by logging, following up, seeking management approval, and closing out. Participate in root cause analysis and corrective action development as needed. + Maintain the change control process by processing document changes and auditing new product setups and labels. + Print and audit batch records, labels, and other required documentation in accordance with the production schedule and established procedures. Control and issue batch records and labels as needed. Support production by printing additional labels/documents and reconciling additional labels. Communicate label stock inventory concerns proactively. + Ensure controlled documents are properly filed, archived, and maintained in accordance with ISO and GMP requirements, including Quality Control Product Files, Batch Production Record packets, and other quality documents. Retrieve archived documentation in a timely fashion. + Maintain label printers through regular cleanings and understand the basic mechanisms of the hardware. + Verify compliance with the Visual Aid program through biannual audits. + Assist in the triennial review of documents. + Fulfill CoA requests to ensure CoAs are provided for external shipments and other customer inquiries in a timely fashion. Essential Skills: + Strong communication and interpersonal skills. + Proven work experience and qualifications as a collaborative and agile team member. + Strong organization and time-management skills. + Proven ability to multi-task and balance speed with accuracy. + Ability to thrive in a fast-paced environment. + Attention to detail is a must. Additional Skills & Qualifications: + Bachelor of Science degree preferred. + 0-2 years of administrative experience. + Administrative skills. + Computer data entry. + Organizational and computer/data entry skills. + Document control. + Quality assurance. + Customer service. + Clinical documentation. Pay and Benefits The pay range for this position is $22.00 - $24.00 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in BROOKFIELD,CT. Application Deadline This position will be accepting applications until Jan 24, 2025. About Aston Carter: Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service. Diversity, Equity & Inclusion At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email astoncarteraccommodation@astoncarter.com (%20astoncarteraccommodation@astoncarter.com) for other accommodation options.