Job Description

Innovative and fast growing company seeking talented and experienced Document Control Assistant.

Come join our team and succeed alongside us!

JOB SUMMARY

The Document Control III is responsible for managing company documents, while also ensuring their accuracy, quality and integrity. These specialists help companies adhere to record retention policies, safeguard information and retrieve data more effectively.

KEY RESPONSIBILITIES AND DUTIES

· Conduct day to day quality documentation processing in support of ongoing projects and daily GMP/GDP operations; maintain documents while ensuring document accuracy, quality, and integrity. Scope includes, but is not limited to; SOP’s, Master Bath Records, Material Specifications, Product Specifications, Packaging Reports, Method Validation Protocols and Method Validation Reports

· Train, support and advise end users on the Document Management System requirements and workflows

· Consult with managers and document reviewers on the triennial review of documents

· Balance workloads and make decisions related to prioritization

· Evaluate document issues and make decision on appropriate follow-up steps based on established processes and escalation to managers as appropriate.

· Contribute to the enhancement and maintenance of the documentation control processes and systems

· Identify opportunities for process and system improvement and enhancement

· Participate in quality and process improvement initiatives and project teams and system integration projects from a document control perspective

· Provide support for internal/external audits and inspections

· May assist with documentation metrics reporting

· Assist with the creation of specification for raw materials and finished products

· Assist with the creation of Master Batch Records and SOP’s

SUPERVISORY RESPONSIBILITIES

· This position has no supervisory responsibilities.

QUALIFICATIONS

REQUIRED SKILLS AND EXPERIENCE

EDUCATION & EXPERIENCE

· Associates Degree in related field; Bachelor’s preferred (OR)

· Three (3) years’ experienced in Document Control, or equivalent combination of education and experience.

· Experience working with an Electronic Document Management System, which maintains and processes document revision as approved by change control

· Experience in a regulated GMP environment and familiarity with the associated terminology and workflow

LANGUAGE

· Proficient skills in reading, writing, speaking and comprehending in English

SKILLS

· Proficiency with Microsoft Word, Excel, Access, PowerPoint

· Ability to read and interpret technical procedures, SOPs, GMPs and government regulations

· Strong written and verbal communication skills

PHYSICAL REQUIREMENTS

WORK ENVIRONMENT

· Approximately 100% of the work is performed on the production floor and warehouse environment.

· Frequently exposed to a variety of extreme conditions at job sites.

· Noise level in the work environment and job sites can be loud

· Routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

· Required to use Personal Protective Equipment necessary for the various environments.

WORK SCHEDULE & BENEFITS

· Typically, M-F, 8:00 AM – 4:30 PM; willing and able to work additional or flexible hours when needed.

· Some weekend and holiday availability required.

OTHER DUTIES

This job description is not an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended, however, to be an accurate reflection of those principal job elements essential for making decisions related to job performance, employee development and compensation. As such, the incumbent may perform other duties and responsibilities as required. Duties, responsibilities and activities may change at any time with or without notice.

Company Description

We want to help job seekers put their talents to work in positions that suit their skills and stimulate their success. We are committed to connecting great companies with great employees and opening up opportunities for both by providing the highest quality of outsourced employment and human resource services.