Label Editor III

Title
:
Label Editor III

Location
:
Columbus, OH

Duration
: 12 Month Assignment

100% Onsite

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Edits, reviews, proofreads, and approves labeling Change Control documentation and associated specifications such as PCCA, OP, MS, PBOM, PMS, etc.
• Reviews labeling for consistency with similar or related product specifications.
• Communicates and coordinates labeling and documentation approvals with other sites.
• Must be able to rearrange priorities on short notice to react to customer needs.
• Responsibilities include implementing and maintaining the effectiveness of the Quality System.

• Minimum education and why it is required.
• BA/BS degree in Science, English, Business, or a related field to ensure accuracy of highly technical information used by manufacturing operations and regulated by the FDA.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Requires a minimum of one to two years of experience in a technical, quality, or operational area.
• Must have the ability to problem solve, manage projects, influence internal and external groups, and provide leadership.
• The incumbent should have strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division.
• Previous experience working within a Change Control system is helpful.
• Knowledge of regulations and standards affecting IVDs and Biologics.

• Labeling and documentation for new products or revisions must be completed accurately and on time.
• Quality of the product is directly linked to the accuracy of the associated documentation.
• Not meeting the scheduling requirements will result in a delay in new product introduction, which can have a far-reaching effect on product sales and can further result in a delay in implementing design improvement, which in turn can affect labor cost and product marketability.
• Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action.
• Documentation associated with the labeling Change Control process must meet Quality, Regulatory, and GMP requirements, as they are official records for audits and legal actions.

• 7–10 years of experience needed.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• Met Life Legal, Met Life , and Met Life Pet Insurance
• 401(k)