COMPLIANCE SPECIALIST III

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We have: - Pay range: 40-50/hr depending on exp. So we can include Pay section with that info. - Schedule? Not mentioned. No schedule details. So omit. - Benefits? Not mentioned. Omit. - About the role: Could be the Position Summary paragraph. That's a prose description. So we can have

About the role

then

with summary. - Responsibilities: The "Essential Areas Of Responsibility" list. That's a list of duties. So

• . - Requirements: The "Position Requirements" includes education/experience etc. Could be Requirements section. - Qualifications: Might overlap with Requirements; but we can separate: maybe Requirements for education/experience, Qualifications for certifications/preferred? But we can combine. However we need to avoid thin sections. Let's see content: Position Requirements: includes Education/Certification/Experience bullet list, then Skills/Knowledge/Abilities bullet list, then Problem Solving paragraph, then TRAVEL REQUIREMENTS: N/A (skip), Constant PHYSICAL REQUIREMENTS... (maybe we can include as part of Requirements? But it's physical requirements; could be part of Requirements but it's detailed. However we might treat as part of Requirements or maybe a separate section like "Physical Requirements". But we only have headings list given; we can add others? The instruction: use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., implying those are examples but we can use others? Probably we should stick to those headings. So we need to map content to those headings. Thus: - About the role: Position Summary paragraph. - Responsibilities: Essential Areas Of Responsibility list. - Requirements: Education/Certification/Experience (maybe also Problem Solving? but that's more skill). Could also include Skills/Knowledge/Abilities under Skills heading. - Qualifications: maybe certifications preferred (ASQ CQE/CQA) etc. Could be under Qualifications. - Skills: Skills/Knowledge/Abilities. - Pay: Pay range. - Schedule: none. - Benefits: none. We must not create sections with filler like "N/A". So skip Travel Requirements, Physical Requirements (since not in allowed headings). But we might need to include physical requirements somewhere? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. If we omit physical requirements, we lose info. However we could include them under a generic heading like "Requirements" maybe as a sub-list? But we only allowed headings from list; we could still include a

  inside Requirements that contains physical requirements. That's okay: we can have a

  Requirements

  and inside include paragraphs covering education, experience, skills, physical requirements, etc. But we also have separate Skills heading. Might be duplication. Better: Use headings: About the role, Responsibilities, Requirements, Skills, Pay. Omit Qualifications if we put certifications under Skills or Requirements. But we need to preserve ASQ certification info. Could put under Requirements as "Preferred qualifications". Or we could have Qualifications heading for certifications. Let's decide: - About the role: Position Summary. - Responsibilities: Essential Areas Of Responsibility list. - Requirements: Education/Certification/Experience bullet list (including preferred years, etc). Also include Problem Solving paragraph? Might be more skill. - Skills: Skills/Knowledge/Abilities bullet list, plus Problem Solving paragraph (maybe as part of skills). Also include ASQ certification? Could be under Qualifications. - Qualifications: Preferred certifications (ASQ CQE/CQA) and maybe other preferred experience (writing QTAs, etc). But many of those are already in Requirements. Might be thin. Given instruction: Prefer a few substantive sections over many thin ones. So maybe combine Requirements and Qualifications into one Requirements section that includes education, experience, certifications, skills, problem solving, physical requirements. Then we could have Skills as separate? That would be thin. Alternative: Have About the role, Responsibilities, Requirements (includes education/experience/certifications/skills/physical), Pay. That's four sections. Let's extract all substantive info: Position Summary: "This position will be responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The position is responsible for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations." Responsibilities list (Essential Areas Of Responsibility): - Prepare and support communication of site quality system status through management review forums. - Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance. - Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations. - Coordinate and manage external audits/inspections, including timely responses and CAPA tracking. - Oversee Inspection Readiness program to maintain site preparedness. - Collaborate with Site Operations and Quality Management to resolve compliance issues promptly. - Conduct Knowledge Management activities, including regulatory review and gap assessments. - Support investigation reviews and corrective action plans, ensuring proper documentation and notification. - Manage vendor/supplier qualification and related compliance activities. - Ensure periodic document reviews and gap assessments for department and site compliance. - Own and update procedures for assigned responsibilities. - Lead special cross-functional projects and present findings to senior management. - Complete required training and maintain compliance with all assignments. - Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records. - Responsible for performing additional related duties as assigned. Position Requirements: - Education/Certification/Experience: Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical or related industry. - Strongly prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry. - Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems. - Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment. - Experience providing support for regulatory agency inspections preferred. - Experience with writing and negotiating Quality Technical Agreements preferred. - Experience in a pharmaceutical manufacturing environment preferred. - Experience with internal/external auditing is preferred. - ASQ CQE/CQA Certification (or equivalent) is preferred. Skills/Knowledge/Abilities: - Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, TrackWise, Veeva, and Qdocs. - Ability to manage multiple priorities and reporting requirements. - Ability to motivate and influence others with and/or without direct supervisory authority. - Ability to communicate effectively with excellent written and oral communication skills. - Ability to interact positively and collaborate with co-workers, management and internal/external partners. - Detail oriented with ability to analyze information, develop possible solutions, create metrics and articulate the link to business needs/objectives. - Project management and advanced presentation skills. - Self-directed with ability to organize and prioritize work. - Problem Solving: Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors. Seeks out all resources when selecting methods and techniques for obtaining results. Acts independently and proactively to recommend and administer methods and procedures for problem resolution. TRAVEL REQUIREMENTS: N/A (skip) Constant PHYSICAL REQUIREMENTS: list (we need to preserve). This includes sitting, finger use, repetitive motions, walking, occasional twisting/reaching, pushing/pulling, grasping, lifting up to 25 lbs, visual acuity, working environment details. We need to preserve that info. Where to put? Could be under Requirements as a subsection. We'll include a

  inside Requirements that contains physical requirements. Thus Requirements section will contain: - Education/Certification/Experience bullet list (maybe as

  ) - Skills/Knowledge/Abilities bullet list (maybe as
  ) - Problem Solving paragraph (as

  ) - Physical Requirements paragraph (as

  ) containing the list. But we also have a separate Skills heading; if we put skills inside Requirements, we might duplicate. Better to have Requirements for education/experience/certifications, and Skills for abilities, problem solving, physical requirements. However physical requirements are not skills but could be under Requirements as well. Given we want few sections, maybe we do: - About the role - Responsibilities - Requirements (includes education/experience/certifications, skills/knowledge/abilities, problem solving, physical requirements) - Pay That's four sections. Let's craft HTML:

  About the role

  This position will be responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The position is responsible for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations.

  Responsibilities

  • Prepare and support communication of site quality system status through management review forums.
  • Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance.
  • Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations.
  • Coordinate and manage external audits/inspections, including timely responses and CAPA tracking.
  • Oversee Inspection Readiness program to maintain site preparedness.
  • Collaborate with Site Operations and Quality Management to resolve compliance issues promptly.
  • Conduct Knowledge Management activities, including regulatory review and gap assessments.
  • Support investigation reviews and corrective action plans, ensuring proper documentation and notification.
  • Manage vendor/supplier qualification and related compliance activities.
  • Ensure periodic document reviews and gap assessments for department and site compliance.
  • Own and update procedures for assigned responsibilities.
  • Lead special cross-functional projects and present findings to senior management.
  • Complete required training and maintain compliance with all assignments.
  • Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records.
  • Responsible for performing additional related duties as assigned.

  Requirements

  • Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical or related industry.
  • Strongly prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry.
  • Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
  • Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment.
  • Experience providing support for regulatory agency inspections preferred.
  • Experience with writing and negotiating Quality Technical Agreements preferred.
  • Experience in a pharmaceutical manufacturing environment preferred.
  • Experience with internal/external auditing is preferred.
  • ASQ CQE/CQA Certification (or equivalent) is preferred.

  Skills/Knowledge/Abilities: Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS),