Full-Time

Quality Assurance Specialist II

Posted on 10/31/2024

PFM

PFM

501-1,000 employees

Financial services for asset management and advisory

Consulting
Financial Services

Compensation Overview

$50k - $86kAnnually

+ Bonus

Junior, Mid

Mansfield, MA, USA

Requires onsite presence in Norton, MA or Mansfield, MA.

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s Degree or equivalent combination of education and experience
  • 2 years of related experience in a life science, regulated environment
  • 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
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): 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
  • 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
  • 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
  • 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

PFM offers financial services including asset management, financial advisory, and consulting, primarily for public sector clients like governments and educational institutions. Their services help clients with investment advice, financial planning, and retirement planning, tailored to meet specific needs. PFM stands out from competitors with its deep expertise in public finance and a client-focused approach, providing specialized teams for areas like transportation finance and economic consulting. The company's goal is to be a trusted partner in helping clients navigate complex financial landscapes and achieve their financial objectives.

Company Stage

Acquired

Total Funding

N/A

Headquarters

Philadelphia, Pennsylvania

Founded

1975

Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for ESG solutions boosts PFM's sustainable investment offerings.
  • Public-private partnerships create new opportunities for PFM's transportation finance team.
  • Digital advisory platforms expand PFM's reach and complement traditional services.

What critics are saying

  • AI-driven advisory services threaten PFM's traditional business model.
  • U.S. Bancorp's acquisition may affect PFM's operational independence and client trust.
  • Failure to meet ESG standards could harm PFM's reputation in sustainable investing.

What makes PFM unique

  • PFM specializes in public finance, serving diverse clients like governments and nonprofits.
  • PFM offers tailored financial solutions, including ESG and transportation finance expertise.
  • PFM's client-focused approach ensures customized financial strategies for unique client needs.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Life Insurance

Disability Insurance

Parental Leave

Paid Vacation

Paid Sick Leave

Performance Bonus

INACTIVE