Quality Specialist I

Aptar Group • Richland Township, PA

5d • $60,000 - $80,000 • Onsite

About The Position

The Quality Specialist I provides administrative and operational support for the maintenance of the Quality Management System (QMS). The role supports document control, audit readiness, records management, and GMP-regulated compliance activities to promote business efficiency and adherence to regulatory requirements, quality standards, and company procedures.

The position assists with internal and external audits; maintains electronic and physical records, training records, and archives; and supports controlled-document review, approval, issuance, and periodic review workflows. It also authors and revises SOPs, forms, and other quality documents, and supports change controls, CAPAs, deviations, and continuous improvement activities. The role compiles monthly quality and compliance metrics and conducts quality reviews and closure of project folders and laboratory reports, including verification of documentation and archival readiness.

Additional responsibilities include controlling laboratory logbooks and notebooks, coordinating equipment calibration, qualification, maintenance, and vendor service activities, maintaining equipment documentation and status, and entering received laboratory materials into electronic inventory systems. The position is based indoors in an office/lab environment, with a 40-hour Monday–Friday workweek. Candidates must be authorized to work in the United States without sponsorship; international relocation is not available.

Requirements

• Four-year degree or equivalent experience in Life Sciences or a related field.
• Minimum 1–2 years of experience, preferably in Quality, manufacturing/laboratory, a regulated industry such as pharmaceutical or ISO, or related fields.
• Strong communication and interpersonal skills for working with clients, team members, and stakeholders.
• Ability to identify data discrepancies and maintain precise, error-free records.
• Must be authorized to work in the United States and not require sponsorship.

Nice To Haves

• Experience with applicable FDA, EMA, ISO 9001, or ISO 17025 standards is preferred but not required.
• Interest in a fast-paced learning environment with an emphasis on applying new skills.

Responsibilities

• Coordinate and assist with scheduling internal and external audits.
• Prepare documentation for inspections and provide on-site audit support, including document retrieval and coordination with QA and laboratory personnel.
• Convert paper records to electronic formats in accordance with data integrity and ALCOA principles; maintain records in electronic systems and physical filing locations.
• Manage off-site archival storage and retrieval of long-term records, maintain employee training records, and support annual training reviews.
• Support administration of the electronic document management system and controlled-document review, approval, effective-date, issuance, and periodic-review workflows.
• Review document change requests for completeness and compliance, and maintain controlled documents and associated records for accuracy, traceability, and version control.
• Author and revise SOPs, forms, and other controlled quality documents in support of continuous improvement, periodic reviews, CAPAs, and quality system deficiencies.
• Author, review, and coordinate change controls, CAPAs, deviations, and related quality records in accordance with established procedures.
• Support maintenance and continuous improvement of the QMS and participate in quality system and compliance initiatives.
• Compile and generate monthly quality and compliance metrics.
• Review project folders and final laboratory reports for compliance with procedures, GDP, and customer requirements; verify completeness, accuracy, and traceability.
• Identify, document, and communicate quality issues or deficiencies to Quality and Laboratory Management, and stop quality review activities when significant compliance concerns are identified.
• Perform final Quality closure of project folders, verify documentation before archival, and ensure electronic project files are scanned and indexed properly.
• Issue, track, archive, and review controlled logbooks and laboratory notebooks for GDP compliance.
• Coordinate equipment calibrations, qualifications, preventive maintenance, and service activities; obtain vendor quotations, initiate purchase orders, coordinate vendor visits, maintain equipment documentation, track equipment status, and support follow-up actions.
• Receive laboratory consumables and materials and ensure proper entry into electronic inventory systems.
• Perform other duties as assigned by management.

Benefits

• 401(k) plan with company matching
• Paid time off
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Personal development and training opportunities through an award-winning corporate university
• Competitive total rewards package; eligible roles may receive discretionary incentive compensation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level