Jobs · Quality Assurance · Massachusetts

Specialist, Quality Control

BioSpace · Norwood, MA · 1 mo ago
Quality Assurance$74k–$118k/yrFull-time
We need to output only HTML fragment, no html/body tags, no markdown fences. We need to include sections only when there is real specific content. The posting includes: - The Role (intro paragraph) – maybe we can treat as a paragraph under no heading? The instruction: 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. So we need headings for sections like "Responsibilities", "Requirements", "Qualifications", "Skills", "Benefits", "Pay". The posting includes "Here’s What You’ll Do" (responsibilities), "Here’s What You’ll Need (Basic Qualifications)" (qualifications/requirements), "Pay & Benefits" (pay and benefits). Also there is "About Moderna" (company description) – could be "About the role"? Actually "About the role" is a heading but we have "The Role" intro paragraph. Could treat that as a paragraph without heading? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't say we must have those exact headings, but we can use them if appropriate. We have content for Responsibilities, Requirements/Qualifications, Pay, Benefits. Also we have "About Moderna" which could be "About the company" but not required. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we can include sections for Responsibilities, Requirements (or Qualifications), Pay, Benefits. Possibly also Skills? The qualifications include skills like problem-solving, communication, etc. Could put under Skills. But we can combine. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from responsibilities and qualifications. We need to use
  • for any list of duties/requirements/benefits, and

    for prose. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we must cut out sections like "Equal Opportunities", "Accommodations", "Export Control Notice", "About Moderna" maybe? Actually "About Moderna" is not boilerplate but it's company description; could be considered substantive? It's not about the role directly but could be considered "About the company". The instruction says we can include sections like About the role, but not About the company? It didn't forbid. However we might keep it as a paragraph under no heading or under a heading like "About Moderna". But the instruction says use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't list About the company. But we could still include a heading like "About Moderna" if we want, but it's not in the list. Safer to omit it, as it's not required. However we must preserve ALL substantive information; does that include company description? It's substantive but not about the role. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. That suggests we should keep all content except boilerplate. The company description is substantive. But we have no prescribed heading for it; we could just put it as a

    without a heading. That's acceptable: we can have prose paragraphs not under headings. The instruction only says use

    for section headings (list). It doesn't forbid other headings, but we should follow the pattern. Probably better to keep it as a

    without heading. Similarly, we need to include the intro paragraph "The Role The Specialist, Quality Control will serve as a key contributor..." That's prose; we can put as

    . Now we need to decide headings: - Responsibilities: from "Here’s What You’ll Do" list. - Requirements / Qualifications: from "Here’s What You’ll Need (Basic Qualifications)" includes education, experience, specific certifications, other quantifiable preference. Could split into Requirements (education, experience) and Qualifications (certifications, preferences). But we can combine under "Requirements". Or we could have "Qualifications" heading for the bullet list of preferences. However the instruction says use headings like Requirements, Qualifications, Skills. We have both. We could do:

    Responsibilities

      ...

    Requirements

    Education: BS in Sciences or relevant scientific field

    Experience: 3-5 years of experience in the biotechnology/biopharmaceutical industry, preferably in a QC, Digital, or Automation role. Familiarity with AI applications, data analysis tools, and digital solutions in a GMP environment is preferred. Understanding of laboratory informatics systems (e.g., LIMS, Chromatography Data Systems) is a plus.

    Specific Certifications or Training: None

    Other Quantifiable Preference: Strong problem-solving skills and ability to troubleshoot AI-related QC processes. Excellent communication skills and ability to work in cross-functional teams. Experience in biopharmaceutical & GMP.

    But the instruction says use
    • for any list of duties/requirements/benefits. The requirements are not a list but could be presented as paragraphs. However we could also make a list for each bullet. The "Other Quantifiable Preference" is a list of skills; we could make a
        . But we can keep as

        . The instruction says use

        • for any list of duties/requirements/benefits. If we have a list, we should use ul. The "Other Quantifiable Preference" is a list of skills; we could make a
            . Similarly, the responsibilities are a list; we should use ul. Pay & Benefits: we have a paragraph describing benefits and then salary range. We need to include Pay and Benefits sections only if posting actually states them. It does state salary range and benefits description. So we can have:

            Pay

            The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

            Benefits

            • Competitive healthcare, plus voluntary benefit programs to support your unique needs
            • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
            • Family planning benefits, including fertility, adoption, and surrogacy support
            • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
            • Savings and investments to help you plan for the future
            • Location-specific perks and extras
            We also have the introductory paragraph about Moderna (the "About Moderna" section). We'll keep as a

            after benefits maybe. We also have the initial "The Role" paragraph. We'll put as

            at top. We must not include headings for Job ID etc. There's none. We must not include application instructions, EEO, accommodations, export control notice. So we cut those. Now ensure we don't include any filler like "commensurate with experience". Not present. Now output only HTML fragment. Let's craft:

            The Specialist, Quality Control will serve as a key contributor to the digital transformation of QC processes, supporting AI-driven initiatives and support of enterprise Lab Systems. The Specialist will collaborate with QC and Digital teams to meet business objectives and assist in the configuration and deployment of Digital systems in QC as needed.

            Responsibilities

            • Provide day-to-day support for QC laboratory systems, including LIMS, Chromeleon, and other enterprise laboratory applications, ensuring reliable system performance and timely issue resolution.
            • Perform routine system administration activities, including user access management, configuration updates, software maintenance, and coordination of system installations and upgrades with Digital teams.
            • Serve as the primary Tier 1 support resource for laboratory computer systems, troubleshooting system issues, documenting resolutions, and escalating complex issues as appropriate.
            • Support implementation, testing, and deployment of system enhancements, software updates, and new functionality to meet QC business needs.
            • Author, revise, and maintain equipment, software, business administration, and system lifecycle documentation, including SOPs, work instructions, and training materials.
            • Support quality system activities related to laboratory software, including deviations, change controls, CAPAs, periodic reviews, and validation documentation, ensuring compliance with GMP and Data Integrity (ALCOA+) requirements.
            • Train and support QC personnel on laboratory software and system functionality, providing guidance on system use and best practices.
            • Participate in continuous improvement initiatives by identifying opportunities to simplify processes, improve system utilization, and enhance the user experience.
            • Support the development, implementation, and continuous improvement of AI-powered and digital solutions that enhance Quality Control laboratory operations, including data review, trending, reporting, and workflow automation.
            • Partner with QC, Digital, and Automation teams to translate business needs into scalable AI-enabled solutions and integrate new technologies into existing QC systems.
            • Ensure AI and digital capabilities comply with GMP requirements, Data Integrity (ALCOA+) principles, and applicable regulatory expectations, including supporting validation, change control, and quality documentation.
            • Monitor the performance and adoption of AI and digital tools, identify opportunities for optimization, and provide training and guidance to QC personnel on new technologies.
            • Collaborate with internal stakeholders, including IT, Digital, and Regulatory teams, to ensure alignment with corporate AI strategies.
            • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
            • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
            • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

            Requirements

            Education: BS in Sciences or relevant scientific field

            Experience: 3-5 years of experience in the biotechnology/biopharmaceutical industry, preferably in a QC, Digital, or Automation role. Familiarity with AI applications, data analysis tools, and digital solutions in a GMP environment is preferred. Understanding of laboratory informatics systems (e.g., LIMS, Chromatography Data Systems) is a plus.

            Specific Certifications or Training: None

            Other Quantifiable Preference: Strong problem-solving skills and ability to troubleshoot AI-related QC processes. Excellent communication skills and ability to work in cross-functional teams. Experience in biopharmaceutical & GMP.

            Pay

            The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful

Similar jobs