Quality Specialist I

AptarGroup, Inc.; Gibsonia (Allegheny County); Sur place; USD 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

401k with company match

Paid time off

Medical, dental, vision

Résumé du poste

Aptar Pharma in Gibsonia, PA is seeking a Quality Specialist I to provide administrative and operational support for the Quality Management System (QMS). You will assist with document control, audits, records management and GMP-regulated compliance to ensure efficiency and adherence to procedures.

Responsibilities include coordinating audits, converting records to electronic formats, maintaining training records, authoring SOPs and supporting CAPAs, deviations, and GDP-compliant project

Qualifications

• Four-year degree or equivalent experience in Life Sciences or related field.
• Minimum 1–2 years of experience, preferably in Quality, manufacturing/laboratory, or regulated industry (e.g., pharmaceutical, ISO).
• Experience with data integrity concepts and ALCOA principles is preferred.

Responsabilités

• Audit support: schedule inspections, prepare docs, provide on-site support.
• Record control: convert to electronic formats and manage records in systems.
• Document control: administer electronic document management and review workflows.
• Quality systems: assist with SOPs, CAPAs, deviations, and related records.
• Data management: generate monthly quality and compliance metrics.
• Project quality review: verify documentation for GDP and customer requirements.
• Logbook & notebook control: archive controlled logs and notebooks.
• Equipment management: coordinate calibrations, maintenance, and vendor actions.
• Asset & material management: receive and enter laboratory consumables.

Connaissances

Strong communication

Attention to detail

Fast learner

Interpersonal skills

Quality systems awareness

Formation

Four-year degree or equivalent in Life Sciences

Description du poste

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!

What You Will Do At Aptar Pharma:

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.

What Aptar Pharma Is Looking For:

• 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.

What you will bring to the journey:

Education:

• Education: Four-year degree or equivalent experience in Life Sciences or related field (or equivalent experience).

Experience:

• Minimum 1-2 years of experience, preferably in Quality, manufacturing/laboratory, or a regulated industry (e.g., pharmaceutical, ISO), or related fields.

Skills:

• 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.

Typical Physical Demands:

(reasonable accommodation may be made to enable individuals with disabilities to perform essential functions)

• Work Location: Indoors, heated/air-conditioned office/lab.
• Work Postures: Position is essentially sedentary; incumbent spends occasional time walking and standing.
• Lifting/Carrying: Occasional lifting/carrying of boxes and supplies up to 50 pounds.
• Equipment: Often uses personal computer and copy machine.
• Visual Activity: Ability to view computer screens, reading scripts and reports, observing experiments (color recognition, depth perception, close-up reading)
• Hearing: Position entails moderate amount of phone contact, incoming and outgoing.
• Work Hours: 40 hours per week, Monday - Friday.
• Typical Mental Demands: Incumbent may encounter some stress in managing multiple projects or performing multiple tasks.

What We Offer

• An exciting, diverse and value based working environment
• Award-winning corporate university offering personal development and training opportunities.

• Competitive base salary
• Contribute to the communities where we reside.
• Innovative benefits plan which includes: 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more

Compensation and Base Annual Pay

Aptar Pharma offers a competitive total rewards package including base salary or base hourly rate determined by many factors including the role, experience, knowledge, skill set and location. For those in eligible roles, discretionary incentive compensation which may be awarded in recognition of individual achievements and contributions.

The typical base annual salary range for the position of Quality Specialist I to the specific work location of: Gibsonia, PA region is USD $60,000 to $80,000 per year. Additional details about total compensation and benefits are provided during the hiring process.

BE YOU, BE APTAR!

Aptar is an Equal Employment Opportunity (EEO) employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information

Aptar Pharma, NA
250 Route 303 North
Congers, NY 10920
www.aptar.com