Document Control Specialist

Planet Pharma; Village of Medina (NY); On-site; USD 24,796 - 27,552; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading pharmaceutical company is seeking a Document Control Specialist in the Village of Medina, NY. This role involves providing clerical support for Quality Assurance documentation, maintaining records, and ensuring compliance with regulations. Candidates should possess a high school diploma, basic office experience, and organizational skills. The position offers competitive pay within a 12-month contract.

Qualifications

• Must have basic clerical skills and office experience.
• Preferred one to two years of office experience.
• Basic computer and word-processing skills required.

Responsibilities

• Provide clerical and administrative support for Quality Assurance documentation.
• Assist with document archival, storage, and destruction.
• Verify scanned copies as true copies.

Skills

Basic knowledge of office equipment

Computer operations

Verbal and written communication skills

Attention to detail

Organizational skills

Multitasking

Customer responsiveness

Education

High School diploma or equivalent

Tools

Microsoft Office Suite

Job description

6 days ago Be among the first 25 applicants

This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$18.00/hr - $20.00/hr

Pay rate: $18-$20/hr

12 month contract

SUMMARY:

Responsible for providing clerical and administrative support for Quality Assurance documentation systems under current Good Manufacturing Practices (cGMP). Main responsibilities include electronic archival of Manufacturing Device History Records (DHRs), including scanning, verification, archival, and transfer of DHRs according to established procedures. Operation of a desktop computer using word processing software and document scanning equipment with applicable software are required competencies,

ESSENTIAL FUNCTIONS:

Assist the Quality Assurance function with Record archival, storage, and destruction, while ensuring compliance with established regulations and standards.

• Preparation of DHR records including removal of staples, ensuring accurate pagination, and compilation of Device Serial Number and Software Version information for transfer to Global Servicing Platform (GSP), as needed.

• Scanning of DHR records using dedicated equipment with applicable software to produce a true copy.

• Verification of scanned copies as true copies i.e. verified to be clear, complete, and legible.

• Perform record archival or destruction according to the Records Retention Schedule and/or established procedures.

• Assist in troubleshooting of document scanner related issues.

• Maintain Document filing and archiving including filing of records checked in to Document Control and transfer of filed records to offsite storage, as needed.

• Perform other duties as assigned

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED:

• Must have basic knowledge of office equipment.

• Working Knowledge of computer operations and a familiarity with applicable software packages (Microsoft Office Suite)

• Verbal and written communication skills

• The ability to pay attention to detail and prioritize workflow is essential.

• Strong Organizational skills

• Ability to multitask and perform tasks efficiently with little or no supervision.

• Ability to identify errors or faults in the process and escalate issue to appropriate personnel when necessary.

• Able to demonstrate responsiveness to customer needs, within job scope.

• Ability to follow specific directions and complete routine tasks within provided guidelines.

EDUCATION/EXPERIENCE REQUIRED:

• High School diploma or equivalent.

• Minimum one (1) - two (2) years office experience.

• Basic computer and word-processing skills.

• Clerical Skills are desirable.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee:

• Must be able to sit, stand, bend, stretch and walk throughout the workday

• Must be able to lift at least 25 lbs

WORK ENVIRONMENT:

The work environmental characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

• Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas.

• Work in close proximity to other employees.

• Work in an environment that is temperature and humidity controlled.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Staffing and Recruiting

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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