Job Details

  • Title: Quality Assurance Associate Specialist
  • Code: RCI-19263-1
  • Location: Carlisle Pennsylvania (PA) 17013
  • Posted Date: 07/30/2020
  • Duration: 12 Months
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  Job Description

Major Job Duties:

  • As a Quality Assurance Associate Specialist, you will be the first line for operational quality advice and support for Production and other site areas. You will drive early detection and help prevent potential quality issues.
  • Supports the release team by performing review of GMP documentation on executed batch records and assisting with resolution of issues in a timely manner
  • Completes real time record reviews as manufacturing records are generated and coaches or mentors individuals to build site capability
  • Provides Quality Oversight for the production areas including Manufacturing, Packaging, and Warehouse and consults on quality issues
  • Investigates and completes Consumer Complaint Investigation Reports
  • May assist or lead Quality Risk Assessments
  • May lead or support changes at the site through the Change Management Process
  • Leads/facilitates/participates/completes cross-functional team investigations utilizing root cause analysis tools
  • Assists in completion of CAPA assigned within the Quality Department
  • Participates in GMP audits and provides product knowledge and support for regulatory responses
  • Works across multiple value streams to promote a quality culture and support continuous improvement
  • Maintains effective communication and partnership with Operations and Materials Management department
  • Coordinates delivery of product samples to the laboratory for shipment, storage, and testing
  • Adapts to changes in the work environment and must be able to change shifts or work overtime and/or weekends as needed.
  • Other duties, responsibilities and qualifications may be required and/or assigned as necessary.

 

QUALIFICATIONS:

  • Bachelor’s degree in a scientific discipline from an accredited college or university required. Candidates with an Associate Degree and a minimum of 4 years cGMP experience in a manufacturing environment may be considered.
  • Ability to demonstrate accuracy and thoroughness while completing work in a timely manner.
  • Strong attention to detail and organizational skills.
  • Knowledge of Technical Writing techniques
  • Effective interpersonal and communication skills.
  • Follows instructions, policies, and procedures.
  • Minimum 1 year of cGMP experience preferred.

 

PHYSICAL/MENTAL REQUIREMENTS:

 

  • While performing the duties of this job, the employee is regularly required to stand; walk, climb stairs or ladders and use hands to handle, or feel.
  • The employee is occasionally required to reach with hands and arms.
  • The employee must regularly lift and/or move up to 50 pounds.
  • The employee is regularly exposed to moving mechanical parts or airborne particles. The noise level in the work environment is usually moderate to loud.
  • The employee must be able to distinguish colors accurately.
  • These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job.