Quality Assurance Specialist II

We need to output HTML fragment with sections: About the role? The description includes intro about Curia and benefits. We need to use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections that have real specific content. We need to preserve all substantive info, not invent or summarize away detail. Remove boilerplate like EEO, legal, etc. Also remove application instructions, cookie/navigation, etc. We need to decide sections: - About the role: Could be the introductory paragraph describing Curia and mission? The job description includes "Build your future at Curia..." and description of Curia. That's about the company, not exactly role. But we can treat as About the role? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include About the role if there is content. The intro includes mission and benefits. Benefits are listed separately later. So we could have About the role: description of Curia and mission. Then Responsibilities: list of essential responsibilities (Floor Presence and Compliance, Data and Documentation Review, Quality Systems, Training and Continuous Improvement, Good Manufacturing & Documentation Practices). Those are subheadings but we can treat as list items under Responsibilities. - Requirements: maybe the "Physical Requirements" and "Work Environment"? Those are more like requirements? But the instruction says Requirements heading for list of duties/requirements/benefits. Could include "Required" qualifications? Actually Qualifications heading is separate. So Requirements could be things like "Must pass background check", drug screen, occupational health screening, physical requirements, work environment. But those are more like "Other Qualifications" and "Physical Requirements". Might be better to put them under Qualifications? However Qualifications heading is for education, experience, skills. The posting has "Qualifications Required" and "Preferred". Also "Other Qualifications". So we can put Required and Preferred under Qualifications. - Skills: maybe we can extract skills from qualifications: critical thinking, problem solving, organizational, attention to detail, communication, proficiency with MS Office, ability to learn systems. Could be a Skills section. - Benefits: The posting lists "Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more!" So we have benefits content. - Pay: Not specified. No pay info. So we should NOT include Pay section. - Schedule: Not specified. So no Schedule. Thus we will have sections: About the role, Responsibilities, Qualifications, Skills, Benefits. Possibly also Requirements? But we have Qualifications covering education/experience etc. The physical requirements and work environment could be under Requirements? But the instruction says we should not create sections with filler like "not specified". Physical requirements are specific. Could be a section "Requirements" for physical demands and work environment. However we already have Qualifications for education/experience. The posting has "Physical Requirements" and "WORK ENVIRONMENT". Those are not qualifications but requirements. So we could make a Requirements section containing those. But we must avoid duplication. Let's see: The posting includes: - Physical Requirements: details. - WORK ENVIRONMENT: details. We can combine them under a Requirements section. Now we need to ensure we preserve all substantive info. Let's extract. About the role: The introductory paragraph: "Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives." Also maybe the benefits list is separate; we will put under Benefits. Responsibilities: The "Essential Responsibilities" section with subheadings: Floor Presence and Compliance, Data and Documentation Review, Quality Systems, Training and Continuous Improvement, Good Manufacturing & Documentation Practices. We need to capture all bullet points under each. We'll convert each subheading's paragraphs into list items under a single

maybe? But we need to preserve detail. Could create
• for each responsibility item. However the subheadings themselves are not list items but categories. We could keep them as inside
• or just include them as part of the li text. Simpler: create a
  with each responsibility bullet as
  • containing the description. We'll need to capture all sentences. Let's extract each: Floor Presence and Compliance: - Provide on-the-floor QA oversight to manufacturing operations, proactively identifying compliance risks and supporting day-to-day quality activities. - Represent Quality Assurance when issues require immediate corrective action, ensuring actions are appropriate, compliant, and accurately documented. - Support the initiation, documentation, investigation, and resolution of deviations and other quality events. - Monitor operations for compliance with approved procedures, batch records, protocols, cGMP requirements, and Good Documentation Practices. - Partner with Manufacturing, Quality Control, Technical Services, and other functions to resolve quality issues, support real-time compliance, and escalate significant concerns to Quality Management. - Provide guidance to personnel regarding cGMP requirements, site procedures, documentation practices, and quality expectations. Data and Documentation Review: - Review Quality Control analytical testing and associated data for completeness, accuracy, traceability, and compliance with approved methods, specifications, SOPs, cGMP requirements, and data integrity principles. - Review analytical documentation, including chromatography and other laboratory-generated data, as applicable, to verify appropriate execution, calculations, results, and adherence to established procedures and specifications. - Identify discrepancies, atypical results, documentation errors, and potential data integrity concerns and partner with laboratory personnel and Quality Management to ensure appropriate evaluation and resolution. - Review manufacturing and quality documentation, including batch records, protocols, controlled forms, and other cGMP records, for completeness and compliance. - Apply sound judgment and critical thinking when reviewing data and documentation and ensure corrections or clarifications are completed in accordance with Good Documentation Practices. Quality Systems: - Author, review, and/or approve Quality Management System documentation, including SOPs, deviations, change controls, CAPAs, controlled forms, and other quality records within assigned authority. - Support investigations through documentation and data review, information gathering, and evaluation of immediate actions. - Maintain Quality databases, electronic systems, training records, controlled documents, archives, and other cGMP records as assigned. - Assist with Quality System metrics and other information used for management review. - Participate in internal audits, client audits, regulatory inspections, and other quality assessments, including gathering and reviewing supporting documentation and completing assigned follow-up actions. - With appropriate guidance, support responses to clients regarding manufacturing, testing, documentation, and quality-related issues. - Support QA visual inspection activities as required. Training and Continuous Improvement: - Maintain required training and provide guidance or training to personnel on cGMP requirements, Good Documentation Practices, site procedures, and other quality requirements within areas of expertise. - Identify opportunities to strengthen compliance, data integrity, documentation practices, and Quality System effectiveness. - Collaborate across departments to promote a culture of quality, accountability, continuous improvement, and proactive problem solving. Good Manufacturing & Documentation Practices: - Perform all documentation in compliance with ALCOA++ principles and site SOPs. - Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms. - Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department. - Apply data integrity principles when reviewing electronic and paper records, including source data, metadata, audit trails, and associated documentation, as applicable. Now Qualifications: There's "Qualifications Required" and "Preferred". Also "Other Qualifications". We'll combine. Required: - Bachelor’s degree in Life Science, Chemistry, Biology, or a related scientific discipline; relevant education and experience may be considered in lieu of a degree. - 3–6 years of Quality Assurance, Quality Control, laboratory, manufacturing, or related experience within a pharmaceutical, biotechnology, medical device, or other FDA-regulated cGMP environment. - Experience reviewing cGMP documentation and/or analytical laboratory data for completeness, accuracy, compliance, and adherence to approved procedures and specifications. - Working knowledge of FDA regulations, cGMP requirements, Good Documentation Practices, and data integrity principles, including ALCOA+. - Ability to identify and evaluate documentation, data integrity, quality, and compliance concerns and appropriately escalate issues when needed. - Strong critical-thinking, problem-solving, organizational, and attention-to-detail skills with the ability to manage multiple priorities in a fast-paced cGMP environment. - Effective written and verbal communication skills with the ability to work independently and collaboratively across functions. - Proficiency with Microsoft Office and the ability to learn applicable electronic Quality, laboratory, documentation, and data management systems. Preferred: - Experience reviewing analytical laboratory and chromatographic data, including HPLC, GC, or other analytical instrumentation and associated data systems. - Familiarity with 21 CFR Parts 210 and 211 and applicable ICH guidance, including ICH Q7, Q9, and Q10. - Experience supporting deviations, investigations, CAPAs, change controls, audits, or regulatory inspections. - Experience working in a pharmaceutical API manufacturing environment. Other Qualifications: - Must pass a background check - Must pass a drug screen - May be required to pass Occupational Health Screening Physical Requirements and Work Environment could be under Requirements section. Physical Requirements: - Regularly required to sit, stand, walk, talk, and hear. - Frequently required to use hands to handle or feel objects, reach with hands and arms, and climb, balance, stoop, kneel, crouch, or crawl. - May occasionally lift and/or move up to 55 pounds. - Visual requirements include close vision, distance vision, peripheral vision, color vision, depth perception, and the ability to adjust focus. Work Environment: - Regular work in a standard office environment, with frequent entry into the production area of a pharmaceutical manufacturing facility. - Production environment may include moving mechanical parts, fumes or airborne particles, extreme heat, wet or humid conditions, low levels of toxic or caustic chemicals, and outdoor weather conditions. - Noise level in the work environment is typically moderate. Also there is a line: "This job description reflects the general nature and scope of the role and is not exhaustive.We’re a growing organization, and opportunities to contribute beyond this list are part of what makes Curia exciting. We’re committed to reviewing reasonable accommodation requests to enable individuals with disabilities to perform the essential functions of this role Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address." This is boilerplate/application instructions/legal. We must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to remove that paragraph. Also remove EEO statement at the end: "Curia is an Equal Opportunity Employer..." etc. Also remove "Curia is an E-Verify employer." So we will exclude those. Now Benefits: The benefits list: "Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more!" We'll put as
    • items. Now Skills