***The QA Specialist II role requires you to be onsite in the Norton, MA or Mansfield, MA lab office location.***

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. In addition, this position is responsible for managing the document and record control system. Extended work hours may be necessary in order to meet business demands.

Essential functions of the job include but are not limited to:

Quality Function:

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):

*Non-Conformances

*Customer Complaints

*Planned Deviations

*Change Management

*Corrective and Preventive Action (CAPA)

*Supplier Quality Management

*Audit Programs

*Employee Training

*Document & Record Control

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

Precision For Medicine

New Jobs

Quality Assurance Specialist