Quality Specialist I

• •This position does not qualify for international relocation. All candidates must be authorized to work in US and not require sponsorship.

Improving Health through Science and Technology! At Aptar Pharma , we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on the Patient Experience. Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry. Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment. Be You, Be Aptar !

The Quality Specialist I is responsible for providing administrative and operational support while assisting in the maintenance of the Quality Management System (QMS). This role supports document control, audit readiness, records management, and GMP-regulated compliance activities to ensure business efficiency and adherence to applicable regulatory requirements, quality standards, and established company procedures.

• •Audit Support:
• •Coordinate and assist with scheduling internal and external audits
• •Prepare and organize required documentation in advance of inspections
• •Provide on-site support during audits, including document retrieval and coordination with QA and laboratory personnel
• •Record Control:
• •Convert paper-based records to electronic formats in accordance with data integrity and ALCOA principles
• •Organize and maintain records within designated electronic systems and physical filing locations
• •Manage off-site archival storage and retrieval of long-term records
• •Maintain employee training records and support completion of annual training reviews
• •Document Control:
• •Support the administration of the electronic document management system by routing controlled documents through review, approval, and effective-date workflows.
• •Review document change requests for completeness and compliance with document control procedures.
• •Maintain controlled documents and associated records to ensure accuracy, traceability, and version control.
• •Monitor document workflows and follow up with stakeholders to support timely document issuance and periodic review activities.
• •Assist in ensuring that controlled documents are current, accessible, and archived in accordance with applicable procedures and record retention requirements.
• •Quality Systems:
• •Author and revise Standard Operating Procedures (SOPs), forms, and other controlled quality documents in support of continuous improvement initiatives, periodic reviews, CAPAs, and identified quality system deficiencies.
• •Author, review, and coordinate Change Controls, CAPAs, deviations, and related quality records in accordance with established procedures.
• •Support the maintenance and continuous improvement of the Quality Management System through participation in quality system activities and compliance initiatives.
• •Data Management:
• •Compile and generate monthly quality and compliance metrics
• •Project Quality Review:
• •Review project folders and final laboratory reports for compliance with applicable procedures, GDP, and customer requirements.
• •Verify the completeness, accuracy, and traceability of project documentation and final reports.
• •Identify, document, and communicate quality issues or deficiencies to Quality and Laboratory Management, including stopping quality review activities when significant compliance concerns are identified.
• •Perform final Quality closure of project folders to ensure compliance with Good Documentation Practices (GDP)
• •Verify completeness, accuracy, and traceability of documentation prior to archival
• •Ensure electronic project files are properly scanned and indexed.
• •Logbook& Notebook Control
• •Issue, track, and archive controlled logbooks and laboratory notebooks
• •Review entries for compliance with GDP
• •Equipment Management
• •Assist in coordinating equipment calibrations, qualifications, preventative maintenance, and service activities.
• •Obtain vendor quotations, initiate purchase orders, and support activities related to equipment services.
• •Support scheduling and coordinating vendor visits, including site access and escorting vendors as required.
• •Maintain equipment-related documentation and support the resolution of service, calibration, qualification, and compliance-related follow-up actions.
• •Assist in tracking equipment status to support continued compliance and operational readiness.
• •Asset & Material Management
• •Receive laboratory consumables and materials and ensure proper entry into electronic inventory systems
• •All of duties as assigned by management .

• •Gateway Analytical is regulated by the FDA and EMA and accredited to ISO 9001 and ISO 17025. Experience with applicable standards is preferred, but not required.
• •Strong communication and interpersonal skills for working with clients, team members, and stakeholders.
• •A keen interest in a fast-paced learning environment with an emphasis on applying new skills.
• •Strong ability to spot discrepancies in data and maintain precise, error-free records.

• •Work Location: Indoors, heated/air-conditioned office/lab.