Manager Quality Assurance - PQA

We need to output HTML fragment with sections: About the role? The posting includes description. We need to use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate: EEO, legal, etc. Also remove application instructions like "Apply now for a career that defies imagination". Also remove duplicated lines. We need to preserve all substantive information. Let's parse content. The posting starts with some marketing fluff: "HOW MIGHT YOU DEFY IMAGINATION? ..." then "At Amgen, our shared mission..." etc. Then "Live What you will do Does the thought of building an entirely new site from the ground up excite you? ..." Actually there is some weird formatting. We need to extract sections: maybe "About the role" (description of role), "Responsibilities", "Requirements" (basic qualifications), "Qualifications" (preferred qualifications), "Skills" maybe from preferred qualifications? "Benefits" maybe from "Thrive Some of the vast rewards of working here ..." includes benefits: Full support and career-development resources, diverse community, generous total rewards plan, compensation and benefits rated above 4 stars. Also "Pay" maybe not specified; we should not include Pay unless stated. There's no explicit salary. So omit Pay. Schedule: mention shift work: "Candidate will be working on site, supporting a shift working schedule, to include late afternoon and nights. Role for Second shift (Example 2pm-10:30pm)." So we have schedule info. Thus sections: About the role (maybe summary), Responsibilities, Requirements (basic qualifications), Qualifications (preferred qualifications), Skills (maybe combine with preferred?), Benefits, Schedule. We must not create sections with filler. Ensure each heading has content. Let's extract content. About the role: Could be the paragraph after "Live What you will do Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion execution excellence and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity. Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027. Lets do this. Lets change the world. Manager Quality Assurance- PQA In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations." We can condense but must preserve all substantive info. We'll include that as About the role. Responsibilities: list bullet points from "Oversee ANC startup activities..." etc. We'll extract each responsibility sentence. Let's list responsibilities from the text: - Oversee ANC startup activities for facilities, utilities, equipment, systems and processes with alignment and integration into the Amgen Quality Systems, including: - Interview candidates to build the ANC PQA team - Author/review/approve quality documents, related to: Standard Operating Procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental & utility qualification protocols/reports, validation protocols/reports, - Oversee execution of, and change management related to, the following: factory acceptance, commissioning tests, facility qualifications and validation activities. - Manage a team of PQA staff and their daily operations (verify training, schedules, ongoing tasks, prioritization and support needed) - Oversee staff/team performance - Prioritize and support staff development - Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations - Participate in Inspection Readiness program activities to ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations - Develop or contribute to the development of procedures and standards by which others will operate - Develop and communicate goals and objectives to staff and key partners - Monitor goal performance and coordinate action for improvement of team and overall Plant Quality Assurance (PQA) performance by championing department operational excellence and Lean efforts. - Assist project teams in establishing priorities, project timelines and in securing resources - Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership - Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change - Review and approve operational and product manufacturing procedures, process validation protocols and reports for manufacturing processes, environmental characterization reports and change control documents. - Support site audits and inspections. We'll put as

• each. Requirements (Basic Qualifications): list bullet points: - Doctorate degree OR Masters degree and 3 years of Quality experience OR Bachelors degree and 5 years of Quality experience OR Associates degree and 10 years of Quality experience OR High school diploma / GED and 12 years of Quality experience - In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. (Note typo "prograns" but keep as is) - Your managerial experience may run concurrently with the required technical experience referenced above - Experience can also include Manufacturing, Operational Excellence, Engineering and/or Data/Information Systems experience We'll keep as bullet list. Preferred Qualifications: list bullet points: - Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources - Experience and training in CDOCS, Trackwise, Maximo, LIMS, MES Werum and other systems and applications - Experience in managing multiple, competing priorities in a fast-paced environment - Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate clearly, facilitate discussions and present to audiences at all levels of the organization. - a site organization with ability to communicate and collaborate effectively with technical and senior management staff. (This sentence seems garbled; but keep as is) - Experience and systems knowledge in areas of manufacturing investigations, Corrective Actions/Preventative Actions (CAPA), product release, validation and/or change control - Ability to develop meaningful team and staff goals, manage performance and coach and undefined (there's weird "and undefined". We'll keep as is? Might be filler but it's part of text. However we should not include filler like "undefined". Might be considered placeholder. Better to omit that line? The instruction: "Do NOT invent or summarize away detail." But also "never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD")". "undefined" is placeholder. So we should omit that line. Similarly later "Ability to manage timelines and deliver results to meet or exceed department undefined". Also placeholder. Also "Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs." That's fine. Also "Thrive" maybe heading? Actually after Preferred Qualifications there is "Thrive Some of the vast rewards of working here". That seems like a heading "Thrive" then benefits. We'll treat "Thrive" as maybe a section heading? But we only allowed specific headings list. Could treat as Benefits. We'll incorporate benefits after. Thus we need to filter out lines with "undefined". Also "Thrive" maybe not a standard heading but we can treat as Benefits. Benefits: from "Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey. A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor." We'll extract benefits bullet points: - Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey. - A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. - Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits (compensation and benefits rated above 4 stars out of 5 on Glassdoor). We'll keep as
  . Schedule: from "Candidate will be working on site, supporting a shift working schedule, to include late afternoon and nights. Role for Second shift (Example 2pm-10:30pm)." We'll put as

  maybe. Now we need to output HTML fragment only, no markdown fences. Structure:

  About the role

  ... (the description)

  Responsibilities

  • ...
  ...

  Requirements

  • ...
  ...

  Qualifications

  • ...
  ...

  Skills

  maybe we can combine some of preferred qualifications that are skills. But we already have Qualifications section for preferred qualifications. Could rename that to "Preferred Qualifications". But allowed headings include Qualifications. We'll use

  Qualifications

  for preferred qualifications. Then we might need a separate Skills section? Could incorporate some skill bullets there. But to avoid thin sections, we could merge preferred qualifications into Qualifications and not have Skills. However the instruction: "Prefer a few substantive sections over many thin ones." So we can have About the role, Responsibilities, Requirements, Qualifications (preferred), Benefits, Schedule. That's six sections. That's okay. We must not include Pay. Now ensure we don't repeat job title as heading. We haven't. Now produce HTML. We need to escape any HTML special characters? The text includes ampersands, parentheses, etc. It's okay as plain text within HTML; but we should escape < and > if they appear. There are some like "cGMP", "GDP", "SOPs", etc. No angle brackets besides those. There's "CDOCS, Trackwise, Maximo, LIMS, MES Werum". No < or >. There's "2pm-10:30pm". No issues. We'll output. Let's craft About the role paragraph: combine the descriptive text up to "Manager Quality Assurance- PQA In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing, including development, clinical, launch and commercial operations." We'll include that as a single paragraph. Now Responsibilities list: we need to break each responsibility into
  • . We'll include the main bullet points as separate
  • . For sub-bullets like under "Interview candidates