Quality Assurance Specialist

We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use

for each heading. Use

• for any list of duties/requirements/benefits. Use

  for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate. Preserve all substantive info. Include a section only when posting has real specific content. So we need to parse the job description. We have: Company Overview: description about company, mission, benefits, website. This could be "About the role"? Actually "About the role" maybe not. Could be "About the company". But headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can map sections accordingly. We have Position Details: Title, Schedule, Location, Salary/Pay Range. We have Position Overview: description of role. Essential Job Functions: list of duties (many bullet-like sentences). That's responsibilities. Qualifications: list of qualifications (minimum 5 years experience, etc.) Desired Skills: MasterControl a plus. Education/Certifications: Bachelor's degree etc. Physical Demands and Work Environment: maybe not required heading; but we could include under Requirements? Not in list. Probably we can omit if not matching headings. But we must preserve all substantive info. Could incorporate into Requirements or Qualifications? The instruction: "Prefer a few substantive sections over many thin ones." We can include sections that match headings; if content doesn't fit any heading, maybe we can still include under appropriate heading like Requirements or Qualifications. However we must not invent sections not in list. So we need to map content to those headings. Let's map: - About the role: Could be Position Overview (general description). Use that. - Responsibilities: Essential Job Functions (list of duties). Use

  • . - Requirements: Could be Qualifications (minimum experience, skills). Or maybe Requirements includes qualifications and education. We'll treat Qualifications as Requirements? But we also have a separate Qualifications heading. The list includes both Requirements and Qualifications. We need to decide what goes where. Typically Requirements = mandatory qualifications; Qualifications = preferred? But we have both. We'll put mandatory experience etc under Requirements, and desired skills/education under Qualifications? However we also have Education/Certifications separate. Could put under Qualifications. Better: Use Requirements for mandatory experience and skills (minimum 5 years QA, analysis skills, FDA cGMP knowledge, ISO 13485, etc). Use Qualifications for education/certifications (Bachelor's degree, ISO Quality System Training, Internal Auditor Training). Use Skills for desired skills (MasterControl a plus). Benefits: list benefits. Pay: salary range. Schedule: schedule info. We also have Location; could be included in About the role or maybe not needed. Could add a short paragraph under About the role. We must not repeat job title as heading. So no heading for Title. We must not include Job ID etc. We must remove boilerplate like company overview website? Actually company overview is substantive; we can keep. We must not include navigation/legal/EEO etc. Not present. Now produce HTML. Structure:

    About the role

    Company overview paragraph + position overview + location maybe.

    Responsibilities

    • ... each duty as li

    Requirements

    • ... mandatory qualifications

    Qualifications

    • ... education/certifications

    Skills

    • ... desired skills

    Benefits

    • ... benefits list

    Pay

    $80,000 - $100,000 annually, based on experience and qualifications.

    Schedule

    8:30 am - 5:00 pm M-F, with some flexibility.

    We need to ensure we preserve all substantive info. Let's extract details. Company Overview paragraph: "We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together! In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities." Position Overview: "The Quality Assurance Specialist ensures products and processes adhere to relevant industry standards, regulations, and specifications by coordinating and supporting activities of the QA Team related to Keystone’s Quality Management System as identified below:" This is intro before duties. Could be part of About the role. Location: "Gibbstown, NJ (08027)". Could add to About the role. Now Responsibilities: list of essential job functions. Let's extract each sentence separated by periods? We'll create li for each distinct duty. List: - Provide general guidance, and/or training to members of the team on Annual Product Reviews (APRs), Internal Audits, Change Management, Complaint Management, CAPA, deviation and Batch Card approval. - When assigned, serve as the lead QA liaison for new project initiatives across new divisions, leading all related QA activities. - Ensure all record requirements for project planning, design control, purchasing activities, customer complaints and other feedback, etc. are met. - Define/clarify cGMP and ISO standard requirements and help coordinate Keystone's efforts for meeting them. - Coordinate/revise/assist with the GMP/GDP training program and ISO Awareness program as needed. - Oversee the Supplier Quality Management System. Work with other department members to qualify suppliers and perform continuous evaluation. Issue and manage supplier corrective action requests. Lead external (supplier) audits and complete associated reports. - Maintain assigned quality system elements, including but not limited to the Internal Audit system, APRs, Customer Complaint Handling, Deviations, Non-Conformances, and CAPA systems. Participate in the completion, review and approval of the documents associated with these systems. - Generate reports to update management on GMP Compliance status. - Perform batch record reviews, ensure follow-up and resolution of any issues, and confirm that all documentation is completed and maintained accurately. - Assist with quality system documentation including but not limited to writing, revising and proof-reading Quality System Procedures, Keystone's Quality Manual, department or task instructions, SOP's, checklists, forms, etc. - Prepare and maintain product technical documents, validation documents, change managements and other technical and quality system documents and records as necessary. - Assist with Management Reviews of the Quality System. Review and summarize trend analysis data as requested such as customer complaints, product and system non-conformances, returns and credit data, CAR/PARs, etc. Prepare or assist with Management Review Reports, Annual product Review Report, data presentation and ensure appropriate meeting minutes are recorded, and follow-up activities are performed and documented. - Advise with project planning, design control and risk assessment responsibilities as necessary. Assist with risk analysis and product Post Market Surveillance activities as required. - Help to update device tech files to meet new regulatory requirements. - Assist with cleaning and process validation activities as needed. - Inform Management of problems found within the quality system and updates on improvements or necessary corrective actions. - Participate in external regulatory, customer and ISO Notified Body audits. Act as SME for QMS related activities. Help coordinate/document resulting corrective action closeout activities. - Create, revise, and manage contractual quality agreements and standards with external partners. - Support company goals/objectives and plans for meeting set goals. - Handle customer communication as necessary. - Complete special assignments and prepare reports/project summaries, as required. - Perform additional duties/tasks as needed or requested by management. That's many. We'll keep them as li. Requirements (mandatory): Minimum 5 years of Quality Assurance and ISO Quality System experience. Relevant experience may be leveraged. Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control, and validation data. Demonstrated FDA cGMP knowledge for medical devices. Pharmaceutical knowledge a plus. Understanding of current ISO 13485 and supporting ISO standard requirements. Demonstrated knowledge of system auditing techniques and requirements. Demonstrated knowledge of FDA’s complaint handling requirements. Demonstrated knowledge of Clinical and Biological Evaluation standards/requirements. Leadership/mentoring skills. Strong decision-making skills. Ability to successfully prioritize and track multiple concurrent/complex projects with minimal guidance. Exceptional interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally. Excellent writing skills. Exceptional project management and organizational skills. Excellent time-management skills and deadline driven. High attention to detail. Proficiency in Microsoft Office applications (Outlook, Excel, Word, PowerPoint). We could split into li each. Qualifications (education/certifications): Bachelor’s degree in a technical field (chemistry, biology, biochemistry, or similar); will consider non-degreed relevant work experience in quality, regulatory, or related field. ISO Quality System Training. Internal Auditor Training. Also maybe Safety compliance? That's under Physical Demands and Work Environment; but we could incorporate into Requirements? But safety is more about work environment; maybe we can include under Requirements as "Comply with all safety regulations; maintains a safe work environment at all times. Adhere to always wearing the proper PPE/Safety equipment. Understand and comply with all written safety, health, and environmental procedures. Attend all required scheduled Health, Safety and Environmental training sessions. Participate in required Health, Safety and Environmental initiatives and programs. Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets." That's a lot. Could be part of Requirements or maybe separate but we don't have a heading for Safety. We could include under Requirements as li items. But we must preserve all substantive info. So we need to include safety details somewhere. Could add under Requirements as li. Physical Demands and Work Environment: Could be included under Requirements as well, or maybe we could add a separate section but not in allowed headings. Since we must only use those headings, we need to fit it somewhere. Perhaps under Requirements we can add a subsection? But we can just add li items for physical demands and work environment. Thus Requirements will be long. Skills: Desired Skills: MasterControl a plus. Benefits: list from Benefits And Perks. Let's extract benefits: - Weekly Pay - Comprehensive Health Coverage - Medical, Dental & Vision Plans - Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options - Company-Paid Life Insurance + Additional Voluntary Options - 401(k) Retirement Plan with 3% Employer Contribution (after 1 year) - Fitness Benefits - Onsite Gym (Headquarters) or Membership Reimbursement (other sites) - Paid Time Off & Holidays to support work-life balance - Employee Assistance Program (EAP) for confidential support - Financial Wellness Resources - Employee Discounts & Perks (Eagles games, concert tickets, etc.) - Company Social Events & Team Activities - Career Development Opportunities & Internal Growth We'll make li each. Pay: "$80,000 - $100,000 annually, based on experience and qualifications." Schedule: "8:30 am - 5:00 pm M-F, with some flexibility." Now produce HTML. We must not include markdown code fences. Just raw HTML. Let's craft. We'll start with

    About the role

    ... combine company