Jobs · Quality Assurance · Massachusetts

Quality Assurance Supervisor

Fagron · Canton, MA · 4 wk ago
Quality AssuranceFull-time
We need to output HTML fragment with sections: About the role? Actually we have "Who We Are" (company description) and "About The Job". The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. Do NOT put Job ID etc. Preserve all substantive info. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to strip the EEO statements at end. Also remove "Explore your future at Fagron Career Site." maybe not needed? It's not substantive? Might be considered boilerplate. We'll keep company description maybe as a paragraph under a heading? There's no explicit heading for company overview; but we could include a section like "About the Company" but not in list of allowed headings. The allowed headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should only include sections when posting has real specific content. So we need to map content: "About The Job" could be "About the role". Then responsibilities list. Then qualifications (basic qualifications). Then maybe skills? The posting includes "Proficient in MS Office programs..." etc. Could be skills. Benefits: "What's on Offer?" includes benefits. Pay: not specified, so we should NOT include Pay section. Schedule: not specified, so omit. Also we might include a short paragraph for company overview? Not required but could be included as a paragraph before sections? The instruction: Output ONLY the HTML fragment. It didn't forbid extra paragraphs not under headings. But better to follow structure: maybe start with a

for company description (Who We Are). Then

About the role

with paragraph summarizing role? The posting has "About The Job The Quality Assurance Supervisor is a leadership level position..." That's the role description. We'll put that as a paragraph under About the role. Then responsibilities: list under

Responsibilities

with
  • each bullet. Need to capture all responsibilities listed. They are many; we need to preserve all substantive info, not summarize away. So we need to list each bullet as separate
  • . The responsibilities include many sub-bullets (Level 1, Level 2, Level 3). We'll need to flatten them? Could keep hierarchical but using
    • only. Could embed sublists? The instruction: Use
      • for any list of duties/requirements/benefits. It doesn't forbid nested lists. But to keep simple, we can make each bullet a line item, preserving the text. We need to include all responsibilities text exactly as given, but we can break into items. Responsibilities list from posting: - Coach and facilitate direct reports’ proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks: Level 1: - Manufacturing / Packaging Line Clearances - Product Label Review and Approval - Product Label Reconciliation - EMS Data Review - Logbook Review and reconciliation Level 2: - Batch Record Issuance - Batch Record Review and Approval - Incoming Material Review and Approval - Form and Logbook Issuance - Review and Approval of Testing Data - Review and Approval of Event Reports and Associated Corrective Actions Level 3: - Disposition and Release of Incoming Materials - Disposition and Release of Finished Product - Document Control Activities - Review and Approval of Change Controls and controlled document changes - Review and Approval of Moderate Risk Deviations - Will have a min of three and a max of seven direct reports at the QA Generalist, Specialist, or Officer levels. - Completes administrative leadership tasks including, but not limited to task scheduling, KPI tracking, and individual performance monitoring. - Demonstrated Subject Matter Expertise or ability to develop expertise in QA responsibilities relevant to assigned QA group (e.g. MQA, QS and Compliance, or other.) - Takes on QA projects of low to high complexity as assigned. - Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes. - Provide QA and compliance guidance and decision making for all manufacturing functions. - Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding. - Lead or assist with problem identification and resolution efforts for quality related issues associated with compounding operations. - Lead or assist with internal, corporate, 3rd party and federal/state inspections and audits. - Lead compilation and analysis of information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned. - Ensure cGMP documentation associated with work activities meets ALCOA standards. - Maintain assigned training standard operating procedures. Monitor training requirements of direct reports. - Perform other related duties as assigned. We need to preserve all that. We'll create
        • for each top-level bullet; for sub-bullets we could nest another
            . That's acceptable. Next: Requirements / Qualifications. The posting has "Basic Qualifications". We'll put under

            Requirements

            maybe? Or

            Qualifications

            . The instruction list includes Requirements, Qualifications. We need to decide which to use. Since they have "Basic Qualifications", we could use Qualifications heading. But also they have "Ability to process information rapidly..." etc which could be skills. We'll separate: Qualifications heading for education/experience requirements; Skills heading for abilities like MS Office, rapid processing, high volume, adaptability, decision making. Thus:

            Qualifications

            • College Degree and greater than ten years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience is required.
            • Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
            • Proficient in MS Office programs, including Word and Excel.
            But the last item is skill; maybe move to Skills. Better: Qualifications: education/experience; Skills: MS Office, ability to process information rapidly, ability to handle high volume, ability to adapt, ability to make quality/compliance decisions. Thus:

            Qualifications

            • College Degree and greater than ten years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience is required.
            • Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.

            Skills

            • Proficient in MS Office programs, including Word and Excel.
            • Ability to process information rapidly from multiple sources and communication channels.
            • Ability to handle a high volume of work and rapidly adapt to changing environment.
            • Ability to make quality and compliance decisions for the site and/or to escalate any questions.
            Benefits: from "What's on Offer?" includes competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off. Also mentions chances to grow, open dynamic environment. We'll include benefits list. Thus:

            Benefits

            • Competitive salaries
            • 401(k) plan with company matching contribution
            • Medical, vision and dental insurance
            • Health savings account (HSA)
            • Holiday/paid time off
            • Opportunities for personal and professional growth
            • Open, dynamic work environment
            We should not include Pay section because not specified. Schedule not specified. We also need to include company description maybe as a paragraph before sections. Could be under a heading like "About the Company" but not in allowed list. Safer to just include a

            with that info at top. Thus final HTML:

            Since 1990, we’ve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better. We’re passionate, science-driven, and always looking for new ways to improve lives.

            About the role

            The Quality Assurance Supervisor is a leadership level position that has direct reports and is responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition or compliance and quality systems. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products. Or, ensures that site quality systems are operating as intended meeting compliance requirements.

            Responsibilities

            • Coach and facilitate direct reports’ proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks:
              • Level 1:
                • Manufacturing / Packaging Line Clearances
                • Product Label Review and Approval
                • Product Label Reconciliation
                • EMS Data Review
                • Logbook Review and reconciliation
              • Level 2:
                • Batch Record Issuance
                • Batch Record Review and Approval
                • Incoming Material Review and Approval
                • Form and Logbook Issuance
                • Review and Approval of Testing Data
                • Review and Approval of Event Reports and Associated Corrective Actions
              • Level 3:
                • Disposition and Release of Incoming Materials
                • Disposition and Release of Finished Product
                • Document Control Activities
                • Review and Approval of Change Controls and controlled document changes
                • Review and Approval of Moderate Risk Deviations
            • Will have a min of three and a max of seven direct reports at the QA Generalist, Specialist, or Officer levels.
            • Completes administrative leadership tasks including, but not limited to task scheduling, KPI tracking, and individual performance monitoring.
            • Demonstrated Subject Matter Expertise or ability to develop expertise in QA responsibilities relevant to assigned QA group (e.g. MQA, QS and Compliance, or other.)
            • Takes on QA projects of low to high complexity as assigned.
            • Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
            • Provide QA and compliance guidance and decision making for all manufacturing functions.
            • Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
            • Lead or assist with problem identification and resolution efforts for quality related issues associated with compounding operations.
            • Lead or assist with internal, corporate, 3rd party and federal/state inspections and audits.
            • Lead compilation and analysis of information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
            • Ensure cGMP documentation associated with work activities meets ALCOA standards.
            • Maintain assigned training standard operating procedures. Monitor training requirements of direct reports.
            • Perform other

Similar jobs