Quality System Associate Specialist

Main Responsibilities:

The Quality System Associate Specialist is responsible for supporting the Quality Systems function through the documentation management and control, and digitization of GMP documentation/records. This role ensures the timely scanning, verification, indexing, and electronic archival of GMP documentation/records to maintain data integrity, document accessibility, and regulatory compliance. The incumbent will also support the issuance, reconciliation, and inventory management of controlled documents, including logbooks, forms, and SOPs, while ensuring adherence to Good Documentation Practices (GDP), Data Integrity (DI) principles, and current GMP/regulatory requirements.

Responsibilities :

GMP Documentation Management

• Support the management of both paper-based and electronic GMP records throughout their retention lifecycle.
• Perform daily scanning of GMP records and documents to support electronic archival and document retrieval activities.
• Verify scanned records for completeness, legibility, accuracy, clarity, and image quality prior to archival.
• Ensure scanned copies are true, complete, and accurate representations of the original records in accordance with data integrity requirements.
• Organize, classify, index, and upload electronic records into designated document management and archival systems.
• Maintain tracking logs for document scanning, archival, retrieval, and reconciliation activities.
• Identify and escalate documentation deficiencies, including missing pages, illegible records, damaged documents, or discrepancies requiring further investigation.
• Support records retention, archival, and destruction activities in accordance with approved procedures and regulatory requirements.

Controlled Document Management

• Print, issue, and reconcile controlled documents, forms, batch records and logbooks to user departments.
• Maintain document issuance registers and reconciliation records to ensure traceability and accountability in accordance with company procedures and regulatory requirements.
• Ensure only current, approved versions of controlled documents are distributed and available for operational use.
• Support document retrieval requests and archival activities in accordance with established procedures.
• Monitor inventory levels of controlled forms and logbooks and coordinate replenishment as required.

Quality Systems Administrative Support

• Support the filing, organization, maintenance, and retrieval of GMP documentation and quality records.
• Assist with document inventory management and routine housekeeping activities within document storage and archival areas.
• Support the preparation and retrieval of documentation required for internal audits, external audits, inspections, and regulatory reviews.
• Assist in tracking and reporting Quality Systems metrics related to document management, archival activities, and record completion status.
• Participate in continuous improvement initiatives aimed at enhancing document control, archival efficiency, and compliance processes.
• Perform additional tasks or assignments as directed by the leadership team.

Experience

• Prior experience in a pharmaceutical, biotechnology, medical device, or other GMP-regulated environment is preferred.
• Experience in document control, records management, scanning operations, archival management, or administrative support functions is advantageous.
• Fresh graduates with strong organizational skills and an interest in quality systems are encouraged to apply.

About You:

• ITE Certificate, Diploma, or equivalent qualification in Life Sciences, Biotechnology, Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, Pharmacy, Quality Management, or a related discipline. Fresh Graduate welcome to apply.
• Knowledge of GMP requirements and applicable regulations, including FDA, EMA, HSA, and PIC/S guidelines, is preferred.
• Understanding of Good Documentation Practices (GDP) and Data Integrity principles is advantageous.
• Experience supporting the implementation or maintenance of quality management systems is an advantage.
• Familiarity with commercial biopharmaceutical quality systems and document management processes is preferred.
• Proficiency in Microsoft Office applications; experience with electronic Quality Management Systems (eQMS) such as MasterControl is advantageous.
• Strong attention to detail with a high level of accuracy in handling GMP documentation.
• Excellent organizational, filing, and records management skills.
• Ability to follow procedures, maintain confidentiality, and manage documentation in a controlled environment.
• Strong learning agility and ability to adapt quickly to new systems, technologies, and processes.
• Ability to work independently while managing routine administrative activities effectively.
• Effective communication and interpersonal skills, with the ability to collaborate across cross-functional teams.

Pay: $2,500.00 - $3,500.00 per month

Experience:

• GMP: 1 year (Preferred)
• ALCOA Principle: 1 year (Preferred)

Work Location: In person