Documentation Control Specialist

Responsibilities

• Maintain the electronic document control system, including all its modules.
• Create Engineering Change orders for Manufacturing Specifications and Standard Operating Procedures (SOPs) and route for approval.
• Monitor Manufacturing and Test Equipment calibration status.
• Maintain the Employee Training Requirements & Records.
• Review current Quality Standards and Regulations, such as ISO 13485:2016 and incorporate any new requirements into the QMS documents.
• Revise and Update SOPs and other Quality Documents as necessary to assure accuracy and relevance or because of audits or failure investigations.
• Aid the Quality Manager during customer and regulatory audits.
• Aid the Quality Manager in failure investigations (Nonconformances, OOS, Complaints).
• Aid the Quality Manager with regulatory inquiries and certifications.

Qualifications

• Required: Bachelor’s degree in scientific discipline or equivalent practical experience.
• Solid understanding of GMP/ISO/USP requirements and data integrity principles.
• Prior successful work experience, preferably in a professional or technical environment.
• Excellent writing and verbal communications skills.

Skills

• Document control
• Quality assurance
• Gmp
• QMS
• ISO 13485
• Non conformants

Top Skills

• Details Document control
• Quality assurance
• Gmp
• QMS
• ISO 13485

Experience Level

Intermediate Level

Job Type & Location

This is a Contract position based out of Dallas, TX.

Pay And Benefits

The pay range for this position is $23.00 - $25.00/hr.

Requirements

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.