Compliance Specialist III

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to extract content: Job Title is given but we must not repeat as heading. Provide location, duration, pay, interview process maybe not needed? The instructions: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Also we should not include interview process? It's not a required heading; we could include under About the role maybe? But we must not invent sections. We can include a short paragraph for metadata like location, duration, pay, interview process perhaps under About the role? However we have separate Pay and Benefits sections if content exists. Pay is given: $45.00 - $50.00 depending on experience. So we should include Pay section with that info. Benefits: Kelly offers various benefits described. So we should include Benefits section summarizing those benefits (but must not invent placeholder). The posting includes benefits: exposure to variety, career guides, access to >3000 online training, weekly pay and service bonus plans, group-rate insurance options, retirement savings plan, service bonus and holiday pay (up to eight paid holidays), transit spending account, paid sick leave, etc. Also mention voluntary benefit plans: medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, legal plan, short-term disability. So we can include Benefits section with that. Schedule: Not mentioned besides 100% Onsite. Could be considered schedule? Not explicit. Might not include Schedule section unless there is real content. The posting says "Location: Salt Lake City, UT–This role is100% Onsite". That's about work arrangement, not schedule (hours). No explicit schedule like full-time, part-time, shift. So we should not create Schedule section. About the role: Could include position summary and maybe location/duration. The "Position Summary" paragraph describes responsibilities. But we have separate Responsibilities section. So About the role could contain brief overview: location, duration, maybe interview process? But we should avoid duplication. The instructions: "Prefer a few substantive sections over many thin ones." So we could combine About the role (position summary) and Responsibilities? But they ask to use headings for those sections if content exists. We have both Position Summary and Essential Areas Of Responsibility. So we can have About the role (position summary) and Responsibilities (list). Requirements: we have Position Requirements (education/experience). Qualifications: maybe certifications? Could combine with Requirements? But they are separate headings. We have "Position Requirements" and "Skills/Knowledge/Abilities". Also "Problem Solving" maybe part of Skills. We could treat Requirements as education/experience, Qualifications as certifications/preferred qualifications, Skills as abilities. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details but can format as lists. We must not repeat job title as heading. Do not put Job ID/requisition numbers as headings (none present). Remove boilerplate: EEO, legal, etc. Also remove "Why Kelly?" sections? Those are promotional but maybe considered boilerplate? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "Why Kelly?" is promotional but not explicitly listed to remove. However it's more like marketing; but it's not required to keep? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. The "Why Kelly?" sections are substantive? They describe benefits of working with Kelly, but we already have Benefits section covering those. The "Why Kelly?" includes some fluff but also mentions access to projects, etc. Might be considered boilerplate? Not sure. Safer to keep relevant benefits but we already captured benefits in Benefits section. The "Why Kelly?" includes some repetitive benefit info; we could omit to avoid duplication. Also "Why Kelly® Science & Clinical?" and "About Kelly Work changes everything." Those are likely boilerplate marketing. We should remove them as they are not specific to the job. Also remove EEO statement at end. Also remove "Requests for accommodation..." etc. Also remove AI notice. Also remove "Kelly may use AI-powered tools..." etc. Thus we will keep: location, duration, pay, interview process maybe not needed but could be part of About the role? The interview process is specific to this role; we could include under About the role as a short paragraph. However the instruction says "Prefer a few substantive sections over many thin ones." Including interview process as its own section would be thin; better to embed in About the role. Thus About the role paragraph: include location (Salt Lake City, UT), duration (2 years with possible extensions), 100% Onsite, interview process (Two Step Interview Process: first virtual via Teams, second in-person including facility tour). Also maybe mention that it's a Compliance Specialist III role (but we shouldn't repeat job title as heading; we can mention it in paragraph). That's fine. Responsibilities: list from "Essential Areas Of Responsibility". We'll convert each sentence into

. Requirements: education/experience: Bachelor’s Degree preferably scientific/engineering, or equivalent education/experience with minimum 7 years relevant progressive experience in pharmaceutical or related industry. Also mention "Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered." We'll include that. Qualifications: maybe include preferred qualifications: Strongly prefer minimum 3 years performing audits and measurements of GMP Quality Systems, preferably in pharma industry. Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to production of pharmaceutical products and associated quality systems. Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for 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 preferred. ASQ CQE/CQA Certification (or equivalent) is preferred. Skills: list from Skills/Knowledge/Abilities and Problem Solving sections. We'll combine. We must not create Pay/Schedule/Benefits sections unless posting actually states them. Pay is stated, so include Pay section with "$45.00 - $50.00 depending on experience". Benefits: we have Kelly benefits description; include Benefits section. Schedule: not stated; omit. Now produce HTML fragment: use

for each section heading, then content:

for prose,

• for lists. We need to ensure we don't include empty sections. Let's craft. About the role:

  Compliance Specialist III position located in Salt Lake City, UT. This is a 100% onsite role with a duration of 2 years, possible extensions. Interview process consists of two steps: a virtual interview via Microsoft Teams followed by an in-person interview on-site that includes a facility tour.

  Responsibilities:

  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:

  Requirements

  Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 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.

  Qualifications:

  Qualifications

  • 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 preferred.
  • ASQ CQE/CQA Certification (or equivalent) is preferred.
  Skills:

  Skills

  • 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 analysis of situations or data and in-depth knowledge 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.
  Pay:

  Pay

  $45.00 - $50.00 depending on experience

  Benefits:

  Benefits

  • Exposure to a variety of career opportunities through Kelly’s expansive network of client companies.
  • Career guides, information and tools to help position yourself throughout every stage of your career.
  • Access to more than 3,000 online training courses via the Kelly Learning Center.
  • Weekly pay and service bonus plans.
  • Group‑rate insurance options available immediately upon hire.
  • Retirement savings plan, service bonus and holiday pay plans (up to eight paid holidays per benefit year).
  • Transit spending account.
  • Entitled to earn paid sick leave under applicable state or local plan.
  • Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability.
  We should not include any extra text like comments. Ensure no markdown fences.