Jobs · Administrative · Virginia

Quality Documentation Specialist

Catalent · Manassas, VA · 1 mo ago
AdministrativeFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes "About Site", "Position Summary", "The Role", "The Candidate", "Why You Should Join Catalent". We need to use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. We need to include sections only when posting has real specific content. We must preserve all substantive info, not invent or summarize away detail. Remove boilerplate etc. We need to map content to appropriate headings. We have: - About Site: description of facility. Could be "About the role"? Actually "About Site" is about facility, not role. Could be "About the role"? Not exactly. But we can use "About the role" heading for role description? The instructions: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose headings that match content. We have sections: About Site (facility), Position Summary, The Role (responsibilities), The Candidate (requirements/qualifications), Why You Should Join Catalent (benefits). Also shift and location info. We need to include shift and location maybe in a short

under some heading? Could be under "About the role"? Or maybe a separate "Schedule" heading if shift info present. Shift: 9am-5:30pm Mon to Fri. That's schedule. So we can create a

Schedule

with

Shift: 9am-5:30pm Mon to Fri, Location: Manassas, VA, 100% Onsite

. That is specific. Pay: not mentioned, so we should not create Pay section. Benefits: we have benefits listed under "Why You Should Join Catalent": Competitive Paid Time Off plus 8 paid holidays, Medical, dental, and vision benefits effective day one, Tuition Reimbursement, Site-based Employee Engagement activities, Employee Resource Groups, environmentally friendly initiatives, Defined career path and annual performance review, WellHub program, Perkspot discounts. So we can create

Benefits

with
  • items. Responsibilities: from "The Role" bullet list (actually paragraph with many responsibilities). We'll extract each responsibility as
  • . Ensure we preserve all details. Requirements/Qualifications: from "The Candidate" includes Minimum Requirements and Preferred Skills & Background. We can split into Requirements (minimum) and Qualifications (preferred) or combine. The instruction says we can have Requirements, Qualifications, Skills sections. We'll create: -

    Requirements

    for Minimum Requirements (must have). -

    Preferred Qualifications

    maybe but heading must be from list: Qualifications. So we can use

    Qualifications

    for preferred skills/background. Skills: maybe we can extract skills like communication, attention to detail, etc. But we already have them in Requirements. Could create Skills section for things like "Strong interpersonal skills", "Strong analytical skills", "Basic Microsoft Office skills". But we might avoid duplication. The instruction: prefer a few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section? But we need to follow headings list; we can choose to include only those with real content. We could have: - About the role (maybe combine About Site and Position Summary? Actually About the role could be Position Summary). We'll use

    About the role

    for Position Summary. - Responsibilities (

    Responsibilities

    ) for The Role. - Requirements (

    Requirements

    ) for Minimum Requirements. - Qualifications (

    Qualifications

    ) for Preferred Skills & Background. - Benefits (

    Benefits

    ) for Why You Should Join Catalent. - Schedule (

    Schedule

    ) for shift/location. We must not repeat job title. No need for Pay. We must remove boilerplate: EEO, accommodation, agency notice, security notice, California notice, volunteer work disclosure, Massachusetts lie detector test notice, etc. We must preserve all substantive info: ensure we don't lose any details from the sections. Let's extract content. About Site paragraph: "About Site The :70,000‑square‑foot Manassas facility operates within Catalent’s Consumer Health portfolio, supporting programs from early development through commercial manufacturing and packaging. It is designed for dietary supplement and food‑safety cGMP operations, making it distinct from Catalent’s traditional pharmaceutical and biologics manufacturing sites." There's a weird "The :" maybe a typo. We'll keep as is but maybe fix spacing: "The :70,000‑square‑foot". We'll output exactly as given? Probably keep the text. Position Summary: "We have an opportunity for a Quality Documentation Specialist to join our team. In this role, you will be responsible for creating and maintaining Quality System documentation and ensuring compliance with industry standards. You will support the Quality Assurance team with special projects and communicate any deviations to management. This position plays a key role in maintaining food safety and quality standards across the site." The Role: a long paragraph with many responsibilities separated by periods. We need to split into list items. Let's list each responsibility: - Create and maintain documentation related to the Quality System using technical writing skills to ensure proper formatting, numbering, and organization of documents such as Master Manufacturing Records, specifications, Batch Production Records, Food Safety and Quality Plans, and other required documents. - Manage the routing and approval process for new documents and process deviations. - Perform internal audits and document all non-conformance to support continuous improvement efforts. - Document all areas of non-compliance with the Quality System and ensure corrective actions are implemented. - Work with Production and Packaging Managers, Supervisors, and Research & Development to maintain and update records and documentation. - Comply with SQF, Food Safety Plan (Hazard Analysis and Critical Control Points), and Food Quality Plan standards. - Ensure compliance with Food and Drug Administration and current Good Manufacturing Practice standards for Quality Control, including continuous training. - Ensure Dietary Supplement’s Identity, Purity, Strength, and Quality. - Document all areas of non-compliance and ensure corrective actions are completed. - Use computer systems to enter and track result data. - Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail. - Review and verify operators' paperwork to ensure they meet quality standards. - Participate in all necessary training required to perform job responsibilities successfully. - Other duties as assigned. Note some duplicates: "Document all areas of non-compliance and ensure corrective actions are implemented." and later "Document all areas of non-compliance and ensure corrective actions are completed." Slightly different wording; we keep both. The Candidate Minimum Requirements: - Must be able to communicate effectively verbally and in written English. - High School Diploma or General Educational Development, with 3+ years of experience in the food industry is required. - Ability to communicate with all line-level positions and management. - Attention to detail. - Self-starter and able to work independently with minimum supervision. - Able to assert themself effectively. - Strong interpersonal skills with the ability to develop cross-functional and multinational relationships to support interaction with various internal customers. - Strong analytical skills. - Ability to read and follow documents such as Standard Operating Procedures and Test Methods. - Knowledge of Good Manufacturing Practice and Quality systems. - Basic Microsoft Office skills (Excel, PowerPoint, and Word). - Must be able to lift and move up to 50 pounds and perform physical activities such as standing, walking, reaching, stooping, kneeling, crouching, crawling, and climbing. Frequent use of hands and ability to talk or hear is required. May also need to taste or smell. Preferred Skills & Background: - Bachelor of Science in Food Science or a related major is preferred. - Knowledge of spoken Spanish is a plus. Why You Should Join Catalent (benefits): - Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. - Competitive Paid Time Off plus 8 paid holidays. - Medical, dental, and vision benefits effective day one of employment. - Tuition Reimbursement – support to finish your degree or earn a new one. - Site-based Employee Engagement activities such as potlucks, cookouts, and monthly birthday recognitions. - Employee Resource Groups focusing on Diversity and Inclusion. - Environmentally friendly, community engagement green initiatives. - Defined career path and annual performance review process with potential for career growth on an expanding team. - WellHub program to promote overall physical and mental wellness. - Perkspot – exclusive discounts from over 900 merchants in various categories. - Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. - Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. - Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. - Join us in making a difference. - personal initiative. dynamic pace. meaningful work. (these seem like fragments; maybe they are part of a tagline. We'll include as part of benefits? They are not clear; but they are substantive? They are vague. Might be considered boilerplate? They are not specific benefits. Might be considered fluff. The instruction: do not include filler/placeholder text like "commensurate with experience", "not specified", "N/A", "varies", "TBD". These are not exactly filler but vague. Might be considered fluff. Safer to omit them? They are part of the "Why You Should Join Catalent" paragraph after the bullet list? Actually the text: "Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities." The last sentence about visiting careers is application instruction, should be removed. The fragments "personal initiative. dynamic pace. meaningful work." maybe tagline; could be considered filler but they are specific words. Might keep as part of benefits? They are not benefits per se. Might be considered fluff. Safer to omit them as they are not concrete benefits. We'll keep the concrete benefits list and maybe the sentences about Catalent's mission etc. But those are also somewhat generic but still substantive about company. The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep those sentences as they are substantive info about the company. However they are not benefits; but we have a Benefits section; we could put them under Benefits? Might be misfit. Perhaps we create a section "About Catalent" but not in allowed headings. We could put them under "Benefits" as they are reasons to join. The heading list includes Benefits; we can include reasons to join there. So we can include those sentences as

    under Benefits. But we must not include application instructions like "Visit Catalent Careers to explore career opportunities." Remove that. Also remove EEO etc. Now Schedule: shift and location. We'll output:

    About the role

    We have an opportunity for a Quality Documentation Specialist to join our team. In this role, you will be responsible for creating and maintaining Quality System documentation and ensuring compliance with industry standards.

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