Administrative Assistant; QA Document Control

Contract Pharmacal Corp; Hauppauge (NY); On-site; USD 45,000 - 65,000; Full time

Job summary

Contract Pharmacal Corp. is seeking a detail-oriented QA Document Control Assistant to support filing, scanning, and organizing GMP records.

You will ensure SOP compliance, retrieve documents for departments, maintain accurate logs, and collaborate with cross-functional teams in an FDA-regulated manufacturing environment.

This role requires strong communication, proficiency with MS Office and ERP systems, and the ability to multitask and prioritize in a fast-paced setting.

Qualifications

• Strong communication and strategic-thinking skills.
• Proficient in using MS Office programs and ERP systems such as Aurantium, and other document management and business communication tools.
• Ability to multitask, prioritize and manage time effectively.
• Some knowledge of cGMPs related to US FDA and manufacturing environments.

Responsibilities

• Assist with the retention and organization of all GMP documents.
• File, scan, and index related GMP documentation.
• Retrieve GMP documents in response to requests from all departments.
• Maintain and improve document logs and the filing system.
• Support intercompany communication and document retrieval requests.
• Review GMP records for accuracy and compliance with Standard Operating Procedures (SOPs).
• Other responsibilities as assigned by senior leadership team.

Skills

Communication

Strategic thinking

MS Office

ERP systems

Time management

cGMP knowledge

Education

High school diploma

Tools

Aurantium

Job description

Position Summary:

Support Quality Assurance Document Control functions, with a specific focus on filing, scanning, organizing, and reviewing GMP records.

Requirements

Responsibilities:

• Assist with the retention and organization of all GMP documents.
• File, scan, and index related GMP documentation.
• Retrieve GMP documents in response to requests from all departments.
• Maintain and improve document logs and the filing system.
• Support intercompany communication and document retrieval requests.
• Review GMP records for accuracy and compliance with Standard Operating Procedures (SOPs).
• Other responsibilities as assigned by senior leadership team.

Education and Experience:

High school diploma; some college coursework or an associate degree is a plus. Previous work experience, preferably in an FDA-regulated industry.

Skills, Abilities and Knowledge:

• Strong communication and strategic-thinking skills.
• Proficient in using MS Office programs and ERP systems such as Aurantium, and other document management and business communication tools.
• Ability to multitask, prioritize and manage time effectively.
• Some knowledge of cGMPs related to US FDA and manufacturing environments

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. May be required to lift up to 50lbs, stand, bend, climb stairs. Specific vision abilities required include close vision, ability to focus. Requires the ability to climb stairs as part of regular duties, including accessing multi-level facilities or transporting documents between floors.

Work Environment:

Required to be present in the office to collaborate with peers and supervisors. Work/Travel schedule must be adhered to and/or changed as needed to meet business requirements. Potential ongoing travel throughout geographic areas on a continual basis as normal scope of role.

Supervisory Responsibilities:

None

Personnel Protective Equipment or Attire Required for Position:

As needed