Sr. Quality Systems Engineer
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. Must not create sections with filler like "commensurate with experience". Pay and Schedule are present: Pay: $45.00 - $50.00 based on experience. Shift Schedule: Monday–Friday, 8:00 a.m.–5:00 pm. So we can include Pay and Schedule sections. Also we have location, duration, interview process maybe not needed? The instructions: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Interview process maybe considered application instructions? It's part of posting but not a section heading we have defined. Could be included in About the role? Probably we can include location, duration, interview process in a short paragraph under About the role or maybe a separate meta paragraph. But we must not create extra headings not in list. So we can put that info in a
under About the role or maybe a general intro. We need to preserve all substantive information: location, duration, pay, schedule, core essential skills, position summary, essential areas of responsibility, position requirements (education/experience), skills/knowledge/abilities, problem solving, why Kelly? etc. However "Why Kelly?" is likely boilerplate/benefits description of the staffing agency, maybe considered not substantive to the job? It's about Kelly benefits. Could be considered benefits section? The instructions: include Benefits section only if posting actually states them. The posting includes Kelly benefits: exposure to career opportunities, career guides, access to training, weekly pay, service bonus, group-rate insurance, retirement savings plan, service bonus and holiday pay, transit spending account, paid sick leave. Those are benefits offered by Kelly. So we should include a Benefits section with those details. Also "Why Kelly? Science & Clinical?" and "About Kelly Work changes everything." That's more boilerplate about the agency; maybe we can omit as it's not specific to the job. The instructions: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "Why Kelly?" sections might be considered boilerplate but they also contain benefits info. We already extracted benefits. The rest can be omitted. We need to avoid duplication. Let's parse the posting: Job Title: Sr. Quality Systems Engineer Location: Salt Lake City, UT –This role is100% Onsite Duration: 2 years with possible extensions Pay: $45.00 - $50.00 based on experience Shift Schedule: Monday–Friday, 8:00 a.m.–5:00 pm Interview Process: Two Step Interview Process. First interview will be virtual via Microsoft Teams. Second interview will be in person, on-site, including a facility tour. Core Essential Skills – Minimum 5 Years Of Experience Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environmentChange Control and Quality Documentation ManagementReview and Approval of SOPs, Protocols, Risk Assessments, and Quality RecordsIndependent Problem-Solving, Sound Judgment, and Decision-MakingStrong Technical Writing and Cross-Functional Communication SkillsCandidates should be senior-level, independent, motivated, and comfortable making higher-level decisions.Experience with compliance or quality systems, documentation review and approval, and strong technical writing skills. Management experience is not required. Position Summary This position is responsible for providing support for the quality management systems (QMS), including documentation management,Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification.The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders.This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control Essential Areas Of Responsibility Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.Responsible for participating in partner, internal and regulatory inspections and audits as needed.Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.Responsible for completing all training requirements and maintaining compliance with all assignments.Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP).Responsible for performing additional related duties as assigned Position 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 discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)Project management and advanced presentation skills preferred Skills/Knowledge/Abilities Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise and Veeva.Self-directed with ability to organize and prioritize work.Ability to motivate, influence and lead others with and/or without direct supervisory authority.Ability to positively manage conflict, provide difficult feedback and negotiate resolution.Ability to build and maintain collaborative relationships between teams, departments and business units.Ability to demonstrate sound judgment and decision making.Ability to communicate effectively with excellent written and oral communication skills.Ability to interact positively and collaborate with co-workers, management and external partners.Ability to analyze information and create metrics relevant to the business objectives.Ability to understand inter-department linkages and alignment of own department with other departments.Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions. Problem Solving Proactively works on problems of a 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. Why Kelly? ... (benefits etc.) Why Kelly® Science & Clinical? ... (maybe not needed) About Kelly Work changes everything. ... (maybe not needed) We need to output only HTML fragment. We'll create sections:
About the role
with paragraph containing location, duration, maybe interview process? But interview process could be considered part of application instructions; we might omit. However location and duration are substantive. We'll include location, duration, and maybe note that it's 100% onsite. Also we could include shift schedule? But we have separate Schedule section. So About the role: location, duration, maybe note that it's 100% onsite.Responsibilities
with- of duties from Essential Areas Of Responsibility.
- Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality/Compliance program related projects as required.
- Hosts the Change Control Review Board and oversees change control activities from initiation through implementation and approval.
- Provides records management and change control expertise to support compliant shutdown planning and execution.
- Ensures efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
- Participates in partner, internal and regulatory inspections and audits as needed.
- Reviews and approves standard operating procedures, protocols, risk assessments and other quality records, as needed.
- Improves and maintains quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
- Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
- Completes all training requirements and maintains compliance with all assignments.
- Maintains work areas and performs job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures
Requirements
maybe combine Education/Certification/Experience and Position Requirements? The instructions list Requirements as a possible heading. We'll put education/experience there.Qualifications
maybe not needed if we already have Requirements. But we could put core essential skills under Skills? Actually we have Skills heading. The core essential skills list could go under Skills. But we also have a separate Skills/Knowledge/Abilities section. We'll map: - Skills: core essential skills (minimum 5 years experience, change control, SOP review, problem solving, technical writing, etc.) plus the Skills/Knowledge/Abilities list. But we must not duplicate. We'll combine. - Requirements: education/experience (Bachelor's degree, 7 years progressive experience, 3 years QA, etc.) - Qualifications: maybe not needed; we could omit if no distinct content. But we have "Position Requirements" already covered. Could also include "Any equivalent combination..." but that's part of Requirements. Thus we may have sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay, Schedule. We must not create Qualifications if no specific content beyond what's in Requirements. Check if any content for Qualifications separate: Not really. Now Benefits: we need to list Kelly benefits: Exposure to a variety of career opportunities as a result of our expansive network of client companies; Career guides, information and tools to help you successfully position yourself throughout every stage of your career; Access to more than 3,000 online training courses through our Kelly Learning Center; Weekly pay and service bonus plans; Group-rate insurance options available immediately upon hire; As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. We'll put those as- items.
Pay: $45.00 - $50.00 based on experience.
Schedule: Monday–Friday, 8:00 a.m.–5:00 pm.
Now we need to ensure we don't include boilerplate like "Why Kelly?" beyond benefits. We'll extract benefits only.
Now produce HTML.
Let's craft:
About the role
Location: Salt Lake City, UT – 100% onsite. Duration: 2 years with possible extensions.
Maybe also mention interview process? Might be considered application instructions; better to omit.