Job Title - CQA Documentation Specialist

Rate - On W2 Contract

Location - Durham, NC, 27709

Job Descriptions:

Roles & Responsibilities:

​The specialist manages the lifecycle of the document from the draft stage, through the review and approval processes, and posts documents for training and as effective.

● Manage the quality document life cycle process to ensure compliance with company procedures and to meet department objectives

● Process change control requests for Clinical and R&D SOPs. Work with Clinical and GPV departments to assist them in processing compliant documents​

Preferred Qualifications:

​Experience with Documentum systems is a plus​

Minimum Qualifications:

​Good Knowledge and understanding of quality and regulatory requirements for the biotechnology and pharmaceutical industry.

Familiarity with quality systems and compliant maintenance of quality-related documentation and records, including knowledge of electronic document control systems.

Proficient in word processing and spreadsheet applications.

Ability to prioritize competing tasks and meet deadlines to ensure compliance.

Excellent oral and written communications skills and the ability to work in a cross-functional and multi-cultural team environment

Education: High school diploma or equivalent

Experience: Typically requires minimum of 1 year of experience with document systems within a Quality Organization or related area in the Biologics, Biotech or Pharmaceutical industry.

Required Skills:

Documentum

systems specialist

Job Type: Contract

Salary: $22.00 - $25.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Health insurance

Experience level:

• 3 years
• 4 years
• 5 years
• 6 years
• 7 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Experience:

• systems specialist: 1 year (Required)
• medical industry: 1 year (Required)
• Medical documentation: 1 year (Required)

Ability to Commute:

• Durham, NC 27709 (Required)

Ability to Relocate:

• Durham, NC 27709: Relocate before starting work (Required)

Work Location: In person