Administrative Assistant; QA Document Control

Contract Pharmacal Corp.; Hauppauge (NY); On-site; USD 42,000 - 55,000; Full time

Job summary

Contract Pharmacal Corp. is seeking an entry-level Support Quality Assurance Document Control professional to assist with the retention, filing, scanning, and indexing of GMP records in an FDA-regulated environment.

The role emphasizes document retrieval, logging, and cross-department coordination. The ideal candidate will have a high school diploma (an associate degree or some college is a plus), strong communication skills, proficiency with MS Office, and familiarity with GMP practices.

Qualifications

• Requires strong communication and organizational skills.
• Experience with MS Office and ERP systems; knowledge of GMP standards.
• Ability to multitask and manage time effectively.
• Familiarity with cGMPs in FDA-regulated environments.

Responsibilities

• Assist with retention and organization of GMP documents.
• File, scan, and index GMP documentation.
• Retrieve GMP documents for requests from all departments.
• Maintain and improve document logs and filing systems.
• Support intercompany communication and document retrieval requests.
• Review GMP records for accuracy and SOP compliance.
• Perform other duties as assigned.

Skills

Communication

Strategic thinking

MS Office

Aurantium ERP

Time management

cGMP knowledge

Education

High school diploma

Some college coursework/Associate degree (plus)

Tools

Aurantium ERP

Document management tools

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