MQA Specialist - 2nd Shift

We need to output HTML fragment with sections: About the role? Actually we have "Who We Are" (company description) and "Position Overview" and "How You’ll Make An Impact" (responsibilities) and "What You’ll Bring" (qualifications/requirements) and "How We Invest In Our People" (benefits). Also maybe "OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT" is boilerplate (EEO etc) we should remove. Also "EQUAL EMPLOYMENT OPPORTUNITY" remove. Also "Want to learn more?" remove. We need headings: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to decide which sections to include based on content. We have: - Who We Are: company description. Could be "About the role"? Actually "About the role" is generic; but we have company overview. Could map to "About the role" or maybe "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It doesn't forbid other headings? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely we should stick to those headings where applicable. So we can have:

About the role

containing the company description and position overview? Might be okay. But we also have Position Overview separate. Could combine. Better: Use About the role for company description and position overview combined. Responsibilities: from "How You’ll Make An Impact" bullet list. Requirements/Qualifications/Skills: from "What You’ll Bring". Could split into Requirements (education, experience) and Skills (communication, etc). But we can combine into Qualifications. Benefits: from "How We Invest In Our People" includes salary range and benefits list. Pay: we have salary range; we could put Pay section with salary range. But we also have benefits; maybe combine Pay and Benefits? The instruction: include a section ONLY when posting has real, specific content for it — never emit heading followed by filler. So we need Pay if salary specified. Yes we have Starting Salary: $64,800-$81,500 USD. So we should have Pay section. Benefits: we have list of benefits. So Benefits section. Schedule: not specified (no mention of shift beyond 2nd shift? Actually title says MQA Specialist - 2nd Shift. That indicates schedule: 2nd shift. So we have schedule info: 2nd shift. Should we include Schedule section? Yes, we have specific content: 2nd shift. So include Schedule. We must not repeat job title as heading. So no heading for MQA Specialist. We must not put Job ID/requisition numbers as headings. We must remove boilerplate: EEO, ethical conduct, etc. We must preserve all substantive information. We need to output only HTML fragment, no /, no markdown fences. We'll produce something like:

About the role

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

The Manufacturing Quality Assurance (MQA) Specialist – 2nd shift is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices. In addition, the MQA Specialist will be responsible for performing routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

Responsibilities

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes.
• Ability to make independent decisions regarding quality related concerns or issues.
• Address daily quality concerns and questions related to operating and environmental issues.
• Clearly communicate complex issues to Management personnel.
• Work closely with production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
• Complete gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Perform aseptic gown training and certification sampling.
• Identify deviations and ensure the deviations are initiated by the appropriate personnel.
• Perform and document assessments of aseptic behavior inside the aseptic manufacturing area. Must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
• Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas. Collect facility waters and submit for testing.
• Requisition of materials, maintaining inventory, and receive and store prepared media. Enumerate bacteria and report excursions, if required.
• Perform additional duties and responsibilities as assigned.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
• Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
• Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

Qualifications

• Bachelor’s degree in science, engineering field, or equivalent experience.
• Minimum one (1) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
• Ability to get gown certified within 30 days.
• Physical requirements include standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.
• Good communication (oral, written) and interpersonal skills are necessary.
• An acceptable visual acuity test is required for this position.

In addition to the minimum qualifications, the employee will demonstrate:

• Embrace Indivior core culture principles.
• Embrace the dynamics of team support, team collaboration and team success.
• Celebrate the core wins of the organization and empower others to sustain a quality mindset.
• Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives.
• Celebrate and embrace diversity, equity and inclusion.
• Proficient knowledge of manufacturing processes and standard operating procedures.

Pay

Starting Salary: $64,800-$81,500 USD (Note actual salary is based on qualifications and experience)

Benefits

• Competitive PTO plus company closure from December 24th- January 1st
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks

Schedule

2nd shift

We need to ensure we didn't include any boilerplate like "OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT", "EQUAL EMPLOYMENT OPPORTUNITY", "Want to learn more?" etc. We removed those. Check that we didn't repeat job title as heading. Good. Check that we didn't include any filler like "commensurate with experience". We didn't. Check that we didn't include any placeholder like "N/A". Not present. Check that we didn't include any duplicated lines. We have some duplication? The responsibilities list includes many items; fine. Check that we preserved all substantive information: company description, position overview, responsibilities list, qualifications, additional qualities, pay, benefits, schedule. Yes. Check that we didn't miss any details: The "How You’ll Make An Impact" includes bullet points; we captured them. The "What You’ll Bring" includes bullet list and additional qualities; we captured both. The "How We Invest In Our People" includes compensation note and benefits list; we captured pay and benefits. The schedule is indicated by title; we added schedule section. Potential missing: "Must be able to demonstrate a sound knowledge of aseptic gowning practices." we included in responsibility bullet. Good. "Perform aseptic gown training and certification sampling." included. "Identify deviations and ensure the deviations are initiated by the appropriate personnel." included. "Perform and document assessments of aseptic behavior inside the aseptic manufacturing area. Must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation." included. "Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas. Collect facility waters and submit for testing." included. "Requisition of materials, maintaining inventory, and receive and store prepared media. Enumerate bacteria and report excursions, if required." included. "Perform additional duties and responsibilities as assigned." included. "Ensure processes and products are in compliance with all local, state, and federal rules and regulations." included. "Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality." included. "Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies." included. Physical requirements: we captured. Good communication: captured. Visual acuity: captured. Additional qualities: captured. All good. Now ensure we didn't inadvertently include any boilerplate like "Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company." We omitted that sentence; we only kept the salary line. That's okay because we preserved substantive info (salary). The instruction says preserve ALL substantive information; does that sentence count as substantive? It's more of a preamble; but we could keep it as part of Pay section. However it's not essential; but we could include it as a sentence. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." The sentence about Fair Pay Acts is not substantive detail about the job; it's a legal notice. Might be considered boilerplate? It's not EEO but it's a legal statement about compensation. It's not essential to the role; but it's part of the posting. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This is legal boilerplate about Fair Pay Acts