Administrative Assistant; QA Document Control

Contract Pharmacal Corp.; Town of Smithtown (NY); On-site; USD 42,000 - 60,000; Full time

Job summary

Contract Pharmacal Corp. seeks an organized professional to support Quality Assurance Document Control. The role focuses on filing, scanning, indexing, and reviewing GMP records to ensure accuracy and SOP compliance.

Responsibilities include maintaining document logs, retrieving records for departments, and assisting with intercompany communications. Some college coursework or an associate degree is a plus, with preference for FDA-regulated industry experience.

Qualifications

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

Responsibilities

• Assist with 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 SOP compliance.
• Other responsibilities as assigned by senior leadership.

Skills

Strong communication

Strategic thinking

Time management

Multitasking

cGMP knowledge

MS Office

Aurantium ERP

Education

High school diploma

Associate degree (preferred)

Tools

MS Office

Aurantium ERP

Job description

Position Summary:

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

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