Company Information

 
Company Name: Scivation
  Address: 1448 Industry Drive
Burlington, NC 27215
  Company Phone: 336-567-0104
Web Site: http://www.scivation.com
   
  Company Description:

Title: Quality and Compliance Manager

Essential Duties and Responsibilities:

·         Accountable for the successful development, deployment and implementation of Supplier Quality Management and New Product Introduction strategies and associated policies, procedures, programs and initiatives that deliver quality/compliance, cost and/or operating benefit to the supply chain

·         Position actively works with suppliers and senior-level management to review on-going performance, to develop and implement quality systems, processes and procedures, and to identify and drive improvement activities

·         Monitor the internal/external environment for changes and trends and assess the impact on projects and suppliers

·         Provide leadership within the Organization, mentor and develop members to adhere to strict compliance with procedures and exercise the highest level of integrity in the tasks performed in a timely and prompt manner

·         Review and approval of Deviation reports, ensuring that procedures are followed for documenting and investigating deviations to determine root cause and implement effective CA/PA

·         Review and approval of Change Controls for production processes and equipment, ensuring that procedures are followed and changes are documented, approved and assessed appropriately

·         Acting as primary customer QA contact for products.  Leading QA meetings with the customer, notifying customers of deviations and changes, and following up on customer requests to provide a high quality of customer service 

·         Supporting product release activities by timely review and closure of deviations and change control assessments

·         Maintaining required training compliance for procedures assigned for position.

·         Perform on-going cGMP training of employees through the current training program.  This will include presenting cGMP training material to new or current employees upon request 

·         Providing monthly summary reports to Supervisor/Manager, as requested

·         Participation in Customer and/or Regulatory Audits and Inspections, as needed

Qualifications:

·         Excellent written and verbal communication skills

·         Must have attention to detail and good investigation, problem solving and organizational skills

·         Ability to work effectively with people and communicate information to obtain positive results

·         Works well with a diverse group of people.  Voluntarily communicates needs and suggestions clearly and effectively

·         Listens and is attentive to others

·         Must have excellent computer skills including Microsoft applications (Word, Excel, Access, PowerPoint)

·         Capable of taking direction and completing assigned tasks on-time

·         Able to manage time efficiently and adjust to changing priorities quickly

·         Must be a strong, dependable team player

·         Independent and capable of efficient time management with minimal supervision

Complexity of Work: The ideal candidate will be deadline focused, detail oriented, well organized and self-motivated along with the ability to juggle multiple projects simultaneously and manage time efficiently.

Education: Life Science (or related) Degree a plus.

Travel:  As necessary.

Experience required: Strong understanding of cGMP compliance regulations and ability apply regulations consistently.

Benefits:

Group Medical and Dental Plan

401K with Company Match

Paid Holidays

Paid Vacation Plan

Relaxed/Casual work environment (not sure if that is the exact language to use, but something to describe we are not corporate and stuffy)

Bonus Structure