Jobs · Finance · Washington

Sr. Associate/Associate QA Compliance

Jubilant HollisterStier CMO · Spokane, WA · 1 mo ago
On-siteFinance$28.81–$33.89/hrFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes description about company, then "Why builders choose us" (benefits/culture). Then job description for QA Compliance Associate and Sr. Associate. Then qualifications. Then location, shift, compensation & benefits. Need to decide sections: Probably "About the role" (company overview), "Responsibilities" (job description), "Qualifications", "Benefits", "Pay", "Schedule". Must not repeat job title as heading. Use

for each section heading. Use
  • for lists. Use

    for prose. We must preserve all substantive info, no boilerplate (EEO, application instructions, etc). Remove duplicated lines. We need to include only sections with real content. Provide Pay and Schedule sections only if posting states them. It does: Compensation & Benefits That Start on Day One includes hiring wage ranges. Also benefits listed. Schedule: Location: Spokane, WA — On Site, Full-Time Shift: Monday-Friday 8am-5pm. Thus we will have sections: About the role (company overview), Responsibilities (job description), Qualifications, Benefits, Pay, Schedule. We must not include filler like "commensurate with experience". We have specific ranges. We need to extract responsibilities: The posting includes two roles: QA Compliance Associate and QA Compliance Sr. Associate. We can combine responsibilities under a single responsibilities section, maybe bullet list. Must preserve all substantive info; we can list responsibilities for each role? Could combine but ensure not lose detail. Probably list responsibilities for Associate and Sr. Associate separately? Could have subheadings? But only allowed headings are

    for sections; we could still have paragraphs describing each role. Use

    for prose. Could include bullet list of responsibilities common to both? Might be lengthy but okay. We need to avoid duplication: The posting repeats some lines (like "Assure product compliance and product safety." appears twice). We should keep only once? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Remove duplicated lines. So we need to deduplicate identical sentences. We'll need to identify duplicate lines and keep one. Let's extract responsibilities text: From first paragraph (Associate): - provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. - Assure product compliance and product safety. - Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. - Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. - Accountable for facilitating Deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval. - Enters data into database in support of the corporate RCA and CAPA activities. - Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks. - Interface with management and responsible individuals to assure task completion on or before established due dates. - Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc…) to assure compliance and product quality and safety. - Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections. - Provide Deviations and CAPA metrics as needed in support of management review of system data. - Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents. From Sr. Associate paragraph: - provides support to the company Deviation, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. - Assure product compliance and product safety. - Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviation, CAPA and vendor complaint activities. - Lead, facilitate, and conduct deviations, non-conformances investigations. - Author/draft investigation reports with minimal guidance. - Ensure timely completion of investigations with accuracy, consistency and compliance with applicableSOPs/Policies, Specifications and related guidelines/regulations. - Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigatereported problems and assess the quality impact. - Conduct investigational meetings with required team member(s) and Verify Investigational findingsagainst documented process per SOP. - Coordinate immediate actions in conjunction with QA and department management upon identification ofa non-conformance. - Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causalfactors. - Facilitate root cause analysis meetings with key stakeholders to identify solutions for qualityimprovements based on identified trends. - Work with cross functional team member(s) to develop appropriate CAPA actions. - Ensure investigations, corrections and CAPA are generated and approved in a timely manner. - Act as liaison as it relates to specific investigations during client calls and audits. - Support and/or coordinate data collection required for management reviews, KPI reports, client trendreview meetings, and all other established regular quality reporting and review mechanisms. - Communicate/Escalate to management any issues or delays identified during the investigation process. - Provide investigation training as needed to the Quality Unit and other departments to ensure thatinvestigations are handled consistently throughout the company. - Speak to assigned deviations during regulatory and client audits. - Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate) We need to deduplicate identical sentences. Many sentences appear in both: "provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues." vs Sr version: "provides support to the company Deviation, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues." Slight difference: "Deviations," vs "Deviation," but essentially same. We'll keep one. "Assure product compliance and product safety." appears both; keep one. "Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities." vs Sr: "Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviation, CAPA and vendor complaint activities." Slight difference singular/plural; keep one maybe. We'll keep both variations? Might be considered duplicate but slight difference. Safer to keep both as they are subtly different. But instruction: remove duplicated lines. If not exact duplicate, keep. We'll produce a responsibilities section with bullet list (

    • ) each responsibility. Now qualifications: There are qualifications for Associate and Sr. Associate. We'll combine? Might be better to have separate sub-sections? But only allowed headings are

      for sections; we could still have paragraphs describing each. Could list qualifications for Associate and Sr. Associate separately within same section using

      or

        . We'll preserve all info. Qualifications text: Associate QA: - Associates Degree in Biology, Chemistry or related field required. - 5 years of experience may be used in a lieu of an Associate’s degree. - Bachelor’s Degree in a science field desired. - Sologic Certificate desired. - Minimum 2 years of experience required. - Bachelor’s degree can be used in lieu of experience. - Pharmaceutical and FDA regulated industry experience desired. - Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired. - Direct or supporting aseptic manufacturing experience in bio/pharma industry desired. - Microsoft Word & Excel required. - Knowledge of cGMPs desired. - Basic exchange of information required. - Managing conflict and influencing outcomes desired. - Provides analysis, diagnosis or production tasks which noticeably impact end results. Sr. QA Associate: - Associates Degree in Biology, Chemistry or related field required. - 5 years of experience may be used in a lieu of an Associate’s degree. - Bachelor’s Degree in a science field desired. - Sologic Certificate desired. - Minimum of 5 years related experience required with an Associate’s Degree. - Minimum of 2 years related experience required with a Bachelor degree. - Pharmaceutical and FDA Regulated Experience required. - Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required. - Direct or supporting aseptic manufacturing experience in bio/pharma industry desired. - Microsoft Word & Excel required. - Knowledge of cGMPs required. - Basic exchange of information. - Managing conflict and influencing outcomes. - Must have demonstrated effective verbal and written communication with all levels of staff. - Must have demonstrated strong interpersonal skills and conflict management. - Must have ability to prioritize investigations based on impact to the facility and release of batches. - Provides analysis, diagnosis or production tasks, which noticeably influence results. - Take leadership or controlling role on end results desired. We need to deduplicate duplicates: Many lines repeat exactly: Associates Degree..., 5 years..., Bachelor’s..., Sologic..., etc. We'll keep one copy for each unique line. For lines that differ (e.g., Minimum years, required vs desired, etc.) keep both. We'll produce qualifications as bullet list. Benefits: From "Why builders choose us:" and later "Compensation & Benefits That Start on Day One". Benefits list: Medical, Dental, Vision, FSA/HSA, Life, AD&D, Disability benefits begin immediately. Also later: Medical, Dental & Vision coverage, Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA), Life & AD&D Insurance, Short-Term & Long-Term Disability Insurance, Employee Assistance Program. Also "Benefits start on day one". We'll combine. Pay: Hiring Wage: Associate QA: $28.81 – $33.89 hourly, with opportunities for growth, promotion, and annual raises. Sr. Associate QA: $81,800 – $109,100 annually, with opportunities for growth, promotion, and annual raises. Schedule: Location: Spokane, WA — On Site, Full-Time Shift: Monday-Friday 8am-5pm. Now About the role: The initial paragraph about company: "Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world. For the Builders, Innovators, and Doers — This Is Your Place If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally. Why builders choose us: Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.A culture of improvement: We value people who thrive on

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