Medical Device Quality Assurance Specialist

3 weeks ago

Frederick, United States Precision For Medicine Full time

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

Position Summary:

The Quality Assurance Specialist III -Medical Device will provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services 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 providing backup for 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:

  • 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 including:
  • Non-Conformances
  • Customer Complaints
  • Planned Deviations
  • Change Management
  • Corrective and Preventive Action (CAPA)
  • Audit Programs
  • Participating on the Material Review Board
  • Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
  • Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions
  • Respond to supplier look-back notifications. Investigate and determine disposition of material
  • Monitor equipment calibration program to ensure timely and accurate completion of maintenance
  • Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
  • Support departmental projects aimed operational process understanding efforts (process mapping)
  • Act as a change-agent and QA lead during continuous improvement and global harmonization efforts
  • Provide guidance to junior level QA specialists
  • Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints for the CDx projects
  • Create and conduct site-wide training for multiple disciplines
  • Support validation activities, including review and approve validation protocols, reports, and final package documentation
  • Support the maintenance and review of DHF and actively participate in all Design Control activities pertaining to the CDx projects
  • 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
  • Inspect and approve all product labels generated by Operations
  • Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
  • Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
  • Maintain filing and storage systems for document control, training and batch records for raw and finished product
  • Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability
  • Inspect 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:

  • May participate actively on the safety committee, as needed
  • 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

Qualifications:

Minimum Required:

  • Bachelor’s Degree or equivalent combination of education and experience
  • 4 years of related experience in a life science, regulated environment
  • In-depth knowledge of ISO 13485 and 21 CFR Part 820 standards

Other Required:

  • Experience working in a Quality Department/Life Sciences-Regulated environment, 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 independently within 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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