Jobs · Quality Assurance · Tennessee

Plant QA Specialist - 4th Shift

Alcami Corporation · Clinton, TN · 1 mo ago
Quality AssuranceFull-time
We need to output HTML fragment with sections: About the role? The posting includes a Job Summary paragraph. Could treat that as "About the role". Also "On-Site Expectations" maybe part of Schedule? Actually schedule is given: 4th Shift: Friday - Sunday, 5:00am - 5:30pm. That's schedule. Also "On-Site Expectations 100% on-site position." That's schedule/location. We'll include a Schedule section with that info. Benefits not mentioned. Pay not mentioned. So we omit Benefits and Pay. We need headings: About the role (Job Summary), Responsibilities, Requirements (maybe Qualifications), Skills (Knowledge, Skills, And Abilities), Schedule (On-Site Expectations + shift). Possibly also Qualifications separate from Skills? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have both Requirements and Qualifications? Might be redundant. Better to follow typical: Requirements (maybe includes qualifications). But we have separate Qualifications and Knowledge, Skills, And Abilities. We could map Qualifications to Requirements section, and Knowledge, Skills, And Abilities to Skills section. Or we could have both Requirements and Qualifications sections if content distinct. The posting has "Qualifications" bullet list and then "Knowledge, Skills, And Abilities". We'll make two sections: Requirements (for the qualifications bullet list) and Skills (for the KSAs). Ensure we don't create empty sections. We need to use

for each section heading. Use
  • for any list of duties/requirements/benefits. Use

    for prose. We must preserve all substantive information, not invent or summarize away detail. Remove boilerplate etc. No application instructions. We need to include all content from Job Summary, Responsibilities (with sub-bullets), Qualifications, Knowledge, Skills, And Abilities, On-Site Expectations (schedule). Also maybe include "Physical Demands and Work Environment"? That's substantive; should we include? The instruction says include a section ONLY when posting has real, specific content for it. Physical Demands is specific content. Should we include a section? There's no predefined heading for Physical Demands, but we could maybe put under a heading like "Physical Demands" but not in the list. The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." Likely they expect only those headings. However they also say "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". So we could add a section for Physical Demands if we want, but not in the given list. Safer to stick to the given headings; we can incorporate Physical Demands into maybe Responsibilities or a separate paragraph under a generic heading? But they said use those headings for section headings; we could still add other headings but they'd be non-standard. Probably better to follow the instruction and only use those headings. Where to put Physical Demands? Could be part of Responsibilities? Not really. Could be a paragraph under a heading like "Work Environment" but not allowed. Might be okay to omit? But they said preserve ALL substantive information. Omitting Physical Demands would lose info. So we need to include it somewhere. Perhaps we can add a section with heading "Physical Demands and Work Environment" as an

    . The instruction didn't forbid other headings; it gave examples. So we can add that heading. Similarly, we might have "On-Site Expectations" which we can put under Schedule heading. Thus sections: About the role (Job Summary), Responsibilities, Requirements (Qualifications), Skills (Knowledge, Skills, And Abilities), Schedule (On-Site Expectations + shift), Physical Demands and Work Environment. We must not repeat job title as heading. No Job ID. Now extract content. Job Summary paragraph: "At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Plant QA Specialist is a hands-on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real-time quality guidance, improve deviation reporting, and support continuous improvement initiatives." We need to preserve all substantive information. The first sentence about Alcami is also part of job summary? It's introductory. We'll keep it. Now Responsibilities: It has headings: Shop Floor Quality & Production Support, Documentation, Batch Records & Material Control, Deviations, Investigations & Compliance, Training & Continuous Improvement. Under each there are sentences. We'll need to turn each bullet into
  • . The content includes multiple sentences per bullet; we can keep them as is. We need to extract each bullet's text. Let's list: Shop Floor Quality & Production Support - Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards. - Serve as the first point of contact for production teams on quality-related questions and issues. - Provide real-time guidance and coaching to operators on GMP requirements and proper documentation practices. - Conduct finished product checks and monitor production activities to ensure products meet release requirements. Documentation, Batch Records & Material Control - Review batch records and production documentation for accuracy, completeness, and compliance. - Support inspection, approval, and release of packaging materials and bulk products. - Maintain retain sample programs and support Right First Time (RFT) performance reporting. - Create, review, and update SOPs, work instructions, forms, and training documentation. Deviations, Investigations & Compliance - Review and approve minor deviations while ensuring timely and accurate documentation. - Support investigations of major deviations through data gathering and root cause analysis. - Assist with CAPAs, risk assessments, change controls, and other quality system activities. - Guide production staff on deviation reporting processes and compliance expectations. Training & Continuous Improvement - Assist in developing and delivering GMP and quality-related training programs. - Support implementation of process improvements to enhance quality, compliance, and efficiency. - Participate in quality projects and help execute operational changes on the production floor. - Collaborate with cross-functional teams to identify opportunities for improving procedures and reducing errors. Now Qualifications (Requirements) bullet list: - Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline preferred. - 2-3 years of experience in a Quality Assurance, Quality Control, or quality-focused support role within pharmaceutical, healthcare, or other regulated manufacturing environments. - Experience performing shop-floor quality inspections and supporting production teams in a fast-paced manufacturing setting. - At least three years of experience working within a Pharmaceutical cGMP Environment is required for consideration. Now Knowledge, Skills, And Abilities (Skills) list: - Ability to review batch records, production documentation, and quality records for accuracy, completeness, and compliance. - Familiarity with deviation management, investigations, CAPAs, root cause analysis, risk assessments, and change control processes preferred. - Experience supporting material inspection, product release activities, and finished product quality checks. - Strong attention to detail with the ability to identify issues, maintain accurate records, and ensure compliance with established procedures. - Experience creating, reviewing, or updating SOPs, work instructions, forms, training materials, or other controlled documents is preferred. - Ability to provide real-time quality guidance to production personnel and effectively communicate quality expectations across teams. - Strong analytical, problem-solving, organizational, and time-management skills. - Demonstrated ability to support continuous improvement initiatives and drive quality-focused process enhancements. - Proficiency with Microsoft Office and electronic or paper-based document management systems. - Excellent verbal and written communication skills, with the ability to collaborate effectively across Quality, Operations, and Production teams. Now Schedule: On-Site Expectations 100% on-site position. 4th Shift: Friday - Sunday, 5:00am - 5:30pm. We'll put under Schedule heading. Now Physical Demands and Work Environment: We'll copy the paragraph. We need to ensure we don't include boilerplate like "Physical Demands and Work Environment The physical demands described here are representative..." We'll keep that. Now produce HTML. Structure:

    About the role

    ...Job Summary paragraph...

    Responsibilities

    • ... etc
    • ...
    We need to group under each subheading? The instruction says use
    • for any list of duties/requirements/benefits. It doesn't require subheadings inside list. But we could keep the subheadings as plain text inside
    • ? Might be better to keep them as part of
    • text. However the original had headings; we could keep them as inside
    • . But not required. We'll preserve the meaning: each bullet preceded by its heading. We'll format as
    • Shop Floor Quality & Production Support: Perform daily quality inspections...
    • etc. That preserves. Similarly for other sections. Now Requirements section: use
      • for each qualification bullet. Skills section: similarly. Schedule section: maybe

        with the two sentences. Physical Demands and Work Environment:

        with the paragraph. Now ensure no extra whitespace. Let's craft. About the role paragraph: combine the introductory sentences and Job Summary. Original: "At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Plant QA Specialist is a hands-on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real-time quality guidance, improve deviation reporting, and support continuous improvement initiatives." We'll keep as is. Now Responsibilities list items: I'll create each

      • with heading bold. Shop Floor Quality & Production Support: - Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards. - Serve as the first point of contact for production teams on quality-related questions and issues. - Provide real-time guidance and coaching to operators on GMP requirements and proper documentation practices. - Conduct finished product checks and monitor production activities to ensure products meet release requirements. We'll combine into one
      • with heading and then the four sub-bullets? Could be nested list but not required. Simpler: make each bullet separate
      • with heading as part of text. Eg:
      • Shop Floor Quality & Production Support: Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards.
      • Shop Floor Quality & Production Support: Serve as the first point of contact for production teams on quality-related questions and issues.
      • ... etc. But that repeats heading. Could also do
      • Shop Floor Quality & Production Support: Perform daily quality inspections...; Serve as first point...; Provide real-time guidance...; Conduct finished product checks...
      • combining sentences with semicolons. That preserves info but changes formatting. Might be okay. Better to keep each bullet separate but include heading only first time? The instruction didn't forbid repetition. I

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