Quality Specialist

Job Title: Quality Specialist - I

Duration: 12 months

Location: Elkhorn, NE 68022

Pay Range: $35 - $ 40/hr. on W2

Must haves:

• Somebody who has worked in a regulated industry (FDA/USDA)

• GMP industry.(Pharma/Vaccine manufacturing/Animal health products or Medical device)

• Experience with change control and change management expertise.

• From quality assurance perspective process lot of change processes within packaging.

• Regulated packaging experience.

• QMS expertise (Trackwise or SAP or Reliance)

Qualifications:

Minimum Requirement:

• High School with at least 3 years of relevant experience or

• Associate’s degree/bachelor’s degree/master’s degree with 1 year of relevant experience in a regulated industry.

Required Experience and Skills:

• Minimum of 2 years of Quality experience in a regulated industry.

• Strong communication skills both written and verbal.

• Experience with investigations, risk assessment, and regulatory inspections.

• Skilled in technical writing.

• Candidates have experience in QMS like SAP, Trackwise and Reliance or similar quality system.

Preferred Experience and Skills:

• Familiarity and/or experience with vaccine manufacturing and specifically packaging.

• Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual.

• Project Management experience.

Position Description:

• This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance for the PS&S (Packaging Simplification and Sustainability) Initiative at the Elkhorn, NE Site.

• This team member will provide guidance to the PS&S team from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.

• This position will serve in the Quality role in Reliance quality systems, Deviation Management and Change Controls for this Packaging Initiative.

• This team member will also be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management.

• They will also assist with other day-to-day packaging related quality questions and inquiries.

• An additional part of the role will be to oversee the update and review SOP’s (Standard Operating Procedures) that relate to the Packaging department.

• Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role.

• A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Assist the local QA teams with other short-term projects and/or site initiatives

• Serve as the back-up for other team members when not in the office.

• Key participant in Quality Compliance Inspections from off-site entities.

• Other tasks as assigned by QA Manager and Quality Director