Quality Assurance Specialist

4 weeks ago

Mansfield, Ohio, United States Precision For Medicine Full time

Job Summary:

The Quality Assurance Specialist II will provide onsite intermediate-level, hands-on support from a regulated systems perspective in a GxP laboratory services, repository, and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components.

Key Responsibilities:

  • Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):
  • Actively participate on Safety Committee
  • Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
  • Maintain monthly metrics and reporting tools for all aspects of quality systems, to include presentation of metric performance to management representatives
  • Respond to supplier look-back notifications. Investigate and determine disposition of material
  • Support laboratory management with monitoring equipment calibration program to ensure timely and accurate completion of maintenance
  • Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
  • Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews

Operations Support:

  • Actively participate in daily operations as an on-the-floor QA representative and conduct process observations to written SOPs/accuracy of batch record/test method execution, and mentor personnel in industry best practices
  • Serve as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentation
  • Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
  • Generate and maintain label formats for manufactured and resale products
  • Generate and maintain Certificates of Analysis for finished products and products for resale
  • Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
  • Develop and distribute controlled quality system documentation
  • Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
  • Develop and maintain databases/spreadsheets for document control
  • Maintain filing and storage systems for document control, training and batch records for raw and finished product
  • Perform area walkthroughs and audits for compliance to written expectations
  • Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability

Inspection and Release:

  • Support inspection and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
  • Perform batch record review and release for finished product, raw materials, intermediate solutions, and services
  • Conduct product inspections, review repack records

Miscellaneous:

  • Assist in training new and existing personnel
  • Participate in regulatory, notified body, and customer audits as needed
  • Provide back-up coverage for other Quality Specialists
  • Carry out other duties/projects as assigned
  • Clinical quality experience preferred but not required

Qualifications:

Minimum Required:

  • Bachelor's Degree or equivalent combination of education and experience
  • 2 years of related experience in a life science, regulated environment

Other Required:

  • Experience working in a Quality Department, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
  • Ability to meet deadlines and perform administrative functions
  • Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
  • Ability to organize tasks, work independently and adapt to changing priorities
  • Ability to function in a minimally supervised environment with exceptional attention to detail required
  • Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
  • Must be able to read, write, speak, fluently and comprehend the English language

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