Quality Assurance Specialist jobs at Res-Care Premier

The Opportunity: Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Role: Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to , governance, financials, contracts, quality and training, and resourcing. Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor. Oversee case management vendor(s) to manage and resolve emerging issues. Develop and/or maintain/ update existing documents for relevant vendor responsibilities. Contributes ICSR quality strategy. Responsible for Global ICSR Reconciliation activities. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required. Your Skills & Abilities: BS/BA, RN, Pharmacist, or equivalent. Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Experience working with third parties (e.g., contract service providers) and relationship management. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: Onboarding Specialist This Is What You'll Do: Plan and coordinate the logistics of new employee onboarding, including scheduling and preparing materials. Conduct orientation sessions to introduce new hires to the company's culture, values, policies and procedures. Schedule and coordinate onboarding activities, providing guidance and support to new hires throughout the process. Ensuring completion of paperwork and following all legal and administrative compliance when onboarding candidates. Assist new hires with completing the necessary paperwork, including employee forms, benefits enrolment, and IT setup. Processes I-9 and E-Verify requests. Processes background checks and drug screens. This Is Who You Are: Excellent interpersonal skills, strong written and verbal communication skills. Highly ambitious and ability to think outside of the box. Eager to share new ideas and contribute to a team. Self-motivated and willing to assume the initiative. Attentive to every detail. Capable of thriving while working independently. This Is What It Takes: 2+ years of experience in onboarding and recruitment with a proven track record of successful onboarding processes and employee retention. Strong knowledge of onboarding best practices, HR policies and procedures, and employment laws and regulations to ensure compliance during the onboarding process. Strong organizational skills to manage and streamline the onboarding process efficiently. Excellent communication and interpersonal skills to build rapport with new employees and establish a positive onboarding experience. Attention to detail and organizational skills to coordinate and manage multiple onboarding processes simultaneously. Adaptability and flexibility to accommodate the diverse needs and backgrounds of new employees. Ability to collaborate and work effectively with remote team members with prior experience in corporate onboarding. Proficiency in Microsoft Office Suite. Proficiency in using HRIS systems and experience with different applicant tracking systems. May require travel to assist field locations with recruitment. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. INNER SATISFACTION. OUTSTANDING IMPACT.

Clinical Quality Assurance Specialist Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs. This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance. ESSENTIAL FUNCTIONS Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials. Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.) Complete required tasks in the electronic quality management system Assist with training coordination, ensuring employees are up to date on quality and compliance requirements Assist with audits of external suppliers Routinely work with internal and external stakeholders to achieve cross-functional goals. Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames. REQUIRED QUALIFICATIONS Education Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline EXPERIENCE 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry PREFERRED QUALIFICATIONS Knowledge of GMP and GCP regulations Strong attention to detail, documentation accuracy, and organizational skills Microsoft Office Experience with MasterControl is desirable Experience with CDER BIMO inspections is desirable COMPETENCIES Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization. Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences. Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders. Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues. Decision-Making/Judgment : Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures. WORK ENVIRONMENT This position can work remotely in the United States. TRAVEL EXPECTATION Up to 10% What you can expect as a Lumosian Industry-competitive compensation Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance. Lumos covers 85 - 95% of the medical premium Health Reimbursement Arrangement 8 weeks of fully paid parental leave for all new parents Gym or fitness class reimbursement 401(k) with 5% employer contribution Flexible work hours and location Generous PTO policy 11 paid holidays in the US Offices in Austin, TX, and Ames, IA

Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Columbus Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Board's direction). Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. Actively seek and lead projects to streamline processes, procedures, and/or practices. Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications Lead Auditor certified (ISO 13485) preferred Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 Training in or good working knowledge of root cause analysis tools Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc…) Advanced PowerPoint skills (i.e. Excel chart linking and template design) Effective technical writing and verbal communication skills. Experience Minimum three years in the medical device industry Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination Minimum two years experience as lead auditor Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Boards direction). Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. Actively seek and lead projects to streamline processes, procedures, and/or practices. Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications Lead Auditor certified (ISO 13485) preferred Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 Training in or good working knowledge of root cause analysis tools Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc) Advanced PowerPoint skills (i.e. Excel chart linking and template design) Effective technical writing and verbal communication skills. Experience Minimum three years in the medical device industry Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination Minimum two years experience as lead auditor Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release. Work schedule: Sunday - Thursday 10:00pm - 6:30am JOB QUALIFICATIONS: High School diploma or GED required; higher learning certifications in an area relevant to role preferred. Minimum one (1) year of experience in a FDA-regulated manufacturing facility. Ability to read and interpret documents in English. Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria. Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred. Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines. Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands. Ability to work both independently and as a member of a team. Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums. POSITION RESPONSIBILITIES : Maintain professional, respectful and positive work environment. Practice acute attention to detail, high level of organization, and error-free performance in all tasks while supporting a fast-paced environment and adapting to changing priorities to meet operations demands. Generate controlled documents (e.g., logbooks, bulk compounding batch records, finished good batch records) for issuance using the Warehouse Management System (i.e., Oracle) and/or Quality Management System (i.e., Agile) as per the current production schedule and/or requests. Document transactions related to controlled document issuance, remittance, review, and release in shared logbooks and trackers as required. Document metrics related to processing batch records for release in shared tracker as required. Communicate with other departments regarding document control activities to ensure timely completion of tasks to support operations and release of finished goods. Review controlled documents (primarily batch records) returned/submitted to Document Control for completeness and correctness to ensure compliance with internal and regulatory criteria; facilitate resolution of observations (e.g., corrections) before release of finished goods and archival of documents. Place and remove product on QA hold when required; ensure Quality Events are resolved and verify disposition to manage bulk and finished goods accordingly. Change product status and close jobs in Warehouse Management System for release of finished goods. Upload required documents (e.g., batch records, customer-required documents) to appropriate shared file locations as required. Maintain the filing system for controlled document archival and destruction as per standard processes; retrieve controlled documents as requested for inspection. Assist with batch-related investigations as requested. Responsible for training employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category. Other reasonable business-related duties as necessary. PHYSICAL REQUIREMENTS: Ability to lift up to 25 pounds. Adequate vision to read controlled documents accurately. BENEFITS: PLD is a proud equal opportunity employer offering many corporate benefits, including: • Medical and Dental Benefits • 401K wirh employer match • Group Life Insurance • Flex Spending Accounts • Paid Time Off and Paid Holidays • Tuition Assistance • Corporate Discount Program • Opportunities to Flourish Within the Company PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #HP1

Job title: QA Specialist Department Division/Location: FLSA Status Quality Assurance Ontario, CA , USA Non-Exempt Position Reports To: Effective Date of Job description: Alternate Lourdes Gonzalez 7-16-2020 Lourdes Gonzalez POSITION SUMMARY A Quality Assurance Specialist performs any kind of testing and validation that will ensure food safety. The tasks will include support project efforts. This position will involves constant improvement of the operations processes. It will also operate as a member of the cross-departmental teams and projects if necessary. EDUCATION Elementary/Some High School High School/GED Post Secondary Education Bachelor's Degree/Master's Required Preferred Required Preferred Required Preferred Required Preferred Certifications: SQF Practitioner HACCP Required Preferred Required Preferred Required Preferred EXPERIENCE Years: 2-5 Special Focus of: Food Manufacturing SKILLS REQUIRED Detail-oriented individuals with analytical minds and strong communication skills. This position should demonstrate the following: Technical Skills - Understanding quality assurance as well as production technologies and systems is crucial in this role Computer Skills - Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations Commercial Awareness - These specialists should be experts in industry standards impacting inspection and quality control techniques and procedures Communication Skills - Strong oral and written communication skills for making presentations and producing testing and quality assurance reports is necessary. Attention to Detail - The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details. Team-Oriented - QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel Analytical Skills - Analyzing production processes and applying this skill to the inspection of products is central to this role Time Management - produce results in a timely manner. PRIMARY RESPONSABILITIES Deviation Analysis Support the analysis and corrective action of deviation that may come from process deviation, complaints, holds, etc. using root cause analysis techniques. Product and Raw Material Testing Support qualification of new product, raw materials and suppliers. Perform inspection on raw material and/or finished goods to check for defects and other product parameters to validate Plant internal programs and processes. Equipment Commissioning Support all tests related to new equipment commissioning and prepare report for further review. Process Validation Support validation plans for Plant's processes. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare detailed reports based on results of validation and qualification tests. Collect and analyze production samples to support process validations. Analyze quality control test results and provide feedback and interpretation to production management or staff. Performs audits of the effectiveness of development processes and products and recommends improvements as necessary Work with upper Management to identify performance improvement opportunities by analyzing quality data and documentation. Documenting/Recording Information Entering data in the QA drive to maintaining information in electronic form to facilitate data analysis. Operations Procedures Support the development of new procedures for Operations that will improvements and/or minimize errors and defects in product. Support operations processes standardization. Continuous Improvement Download quality and production information form Aptean system and perform monthly reviews and targets. Support and/or develop QA test trends and as need. Training Support Plant training program by creating training material for Quality and Production and consequently employee training. Safety Participate in, and support all safety program elements, directed towards meeting the plant's TIR (Total Incident Rate) goal established each year. This includes safety training, inspections, incident investigations, incentive programs, and any other safety-related activities. Comply with all company policies and procedures including safety rules. Food Safety and Quality Adheres to all Food Safety/Quality SOP's Communicates any known or suspected Food Safety/ Quality issues to the Production Manager or Supervisor, Q.A. Department or Management. Attends Food Safety/Quality training sessions.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Under supervision, assist with documentation for the closure of investigations. * Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. * Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School or GED diploma required. Associate's degree or equivalent years of experience preferred. * Experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * PC Skills Required (MS Word, Excel). * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelor's degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 8:30 AM - 5 PM KEY RESPONSIBILITIES Batch Review and disposition: Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. Review and approve Master Batch Records. Perform the review of records and determine disposition of: Medical Devices Packaged/Labeled Medical Devices Clinical Product Investigations and CAPAs. Perform the review of Testing Specifications. Validation Coordinate and monitor validation activities. Provide support during regulatory inspections of GMP Contractors and LCI facilities. Assist in performing inspection readiness activities. Review Quality Agreements. Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. Provide updates to Manager, BioMed Operations. QUALIFICATIONS Bachelor's Degree in a life science-related discipline or equivalent work experience. Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers. Knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. Ability to exercise strong risk-based business judgment. Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally Good investigation and monitoring skills. Current knowledge of QC testing methods. Attention to detail and implementation of good documentation and GMP processes is essential. Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. Why LCI? Purpose-driven company driven by principles, not profit Reach your highest potential: upward mobility, rewarded through hard work Competitive salary and compensation Basic Life Insurance at no cost to the employee 401(k) with match and Surplus-Sharing Plans Health, Dental, and Vision Insurance Ten paid holidays annually Paid Time Off (PTO) On-site Health and Wellness program Employee Assistance Program (EAP)

Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Denver for our 1st shift. Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Schedule: Monday to Friday 6 AM until 3 PM Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

Are you ready to embark on a career where innovation meets excellence? At Jost Chemical Company, we're on a mission to push the boundaries of chemical manufacturing, delivering high-quality products that make a positive impact on global industries. If you're passionate about chemistry, dedicated to precision, and eager to contribute to a company that values both innovation and integrity, explore our exciting job opportunities. Join us in shaping the future of chemical manufacturing at Jost Chemical Company, where your career is more than just a job - it's a journey of growth and achievement. Then, this position is right for you! Founded in 1985, Jost Chemical is a global leader in the manufacture of high purity mineral salts for the nutritional, pharmaceutical and specialty markets. Expansion, growth of capabilities, and investment in people, lab and production equipment have been a part of Jost's company culture for 35 years. To learn more about Jost Chemical please visit ******************** Our offer: * Shift Differential * Medical/Dental/Vision Plan Insurance, Short and Long-Term Disability and Life Insurance first of the month following 60 days. * 401k plan which includes safe-harbor contribution and discretionary match. * Paid Time Off (PTO) Employees eligible first day of employment. * 9 Company Paid Holidays (72 hours) each year. * Uniforms Provided * Foot Protection- annual allowance for all laboratory, maintenance and production employees. * 24-hour access to our free, on-site fitness center. * We provide Individual development, on-the-job training, and development programs designed to enhance your professional growth and development while ensuring you feel valued, inspired and appreciated at work. Jost Chemical is an equal opportunity employer and affirmatively seeks diversity in its workforce. We consider applicants, and make all employment decisions, without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, or any other legally protected status. We are committed to recruiting and retaining the best talent in the chemical manufacturing industry. The Quality Assurance (QA) Specialist in Pharmaceuticals is responsible for ensuring that all products and processes meet established standards of quality, including reliability, usability, and performance. This role involves developing, implementing, and maintaining quality assurance systems and activities to ensure compliance with regulatory requirements and internal standards. The QA Specialist will work closely with cross-functional teams, including manufacturing, regulatory affairs, and R&D, to support continuous improvement initiatives and ensure product safety and efficacy. Job Responsibilities: * Work in a GMP regulated environment to provide and assist in implementation of quality-related activities. * Provide expertise and guidance in interpreting policies, regulatory guidelines, and regulations to ensure compliance and act as departmental resource for cGMP programs. * Provide QA support and be a primary point of contact for quality systems and other operational systems, provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines. * Review and approve procedures and documents against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports. * Author SOP's, protocols, validation plans and compliance documents for cGMP program. * Author and review validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix Review. * Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements. * Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software. * Perform periodic reviews for all validations and qualifications. * Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections. * Identify and implement continuous improvement efforts for the quality systems to ensure alignment with regulatory regulations/guidance. * Maintain, enforce and improve Food Safety Program/ HACCP/ FSSC 22000 certification. * Performs internal audits, self-inspections in areas including quality control, manufacturing, warehousing, packaging, food safety. Ensures observations are corrected. * Present data during department and cross-functional meetings as needed. * Coordinate and liaise with other departments to facilitate uniform quality standards for the site. * Review and approve Change Control records acting as a subject matter expert, ensuring compliance with internal policies, procedures, and guidelines. * Perform and conduct risk assessments for various GMP topics. * Perform other activities as required based on company needs. * Administrator of Quality Management Software Qualifications: * A Bachelor's Degree is essential, preferably in a relevant scientific field like Chemistry, Biology, Biochemistry, or Microbiology. * Preferred at least 5 years of experience in the biopharmaceutical industry, with progressive involvement in Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience. * Exceptional written and verbal communication abilities. * Knowledgeable in instrument, equipment, facility, clean rooms and software qualification - validation. * Experienced in auditing suppliers, analytical contract labs and vendors. * Knowledge of annual product review and stability study protocols per ICH. * High level of knowledge in cGMP guidelines as specified in ICH Q7A. * Working knowledge of 21 CFR Parts 11, 210, and 211 * Experience conducting audits of internal and external operations preferred. * Certification as a Quality Auditor or an equivalent qualification preferred. * Proficiency in computer operations, including experience with SAP and various reporting and data analysis tools such as Word, Excel, Visio, JMP, and Minitab.

Description About Orsini Specialty PharmacyProviding compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™. Our MissionOrsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. LIVE IT ValuesAt the heart of our company culture, the Orsini LIVE IT core values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-FirstPay Range: $19-$24 HourlyThe Quality Assurance Specialist will be responsible for supporting the Quality Team in carrying out the quality management systems at Orsini, with a primary focus on internal audits and quality checks. This role will assist in monitoring compliance with contracts, regulatory requirements and accreditation standards by performing safety data quality checks and routine audits, documenting findings and supporting corrective actions. The specialist will also provide support with other aspects of the quality system as needed, which may include vendor management, quality metrics, deviation and CAPA tracking, and document control. By assisting in these activities, the specialist helps ensure the provision of optimal pharmaceutical care to patients and clients of Orsini Healthcare. Required Knowledge, Skills & Training • Previous experience in a pharmacy, healthcare quality, or compliance setting required; specialty or mail-order pharmacy experience preferred. • Knowledgeable in electronic medical record systems and able to navigate and review patient charts for accuracy and completeness required • Experience with internal audits or compliance monitoring is preferred. • Familiarity with pharmacovigilance activities, including adverse event reporting and case management, preferred. • Familiarity with pharmacy accreditation standards (URAC, ACHC, or similar) a plus. • Strong computer skills - Microsoft Excel, Word, PowerPoint, and Visio • Strong attention to detail with excellent organizational and documentation skills. • Effective written and verbal communication skills. • Ability to follow structured processes and work independently while collaborating across teams. Essential Job Duties• Review electronic medical records to verify correct reporting and documentation of safety events. • Review electronic medical records and patient charts to identify errors, omissions, or potential compliance issues. • Conducts audit of pharmacovigilance case reports, adverse event documentation and related records to ensure accuracy, completeness, and compliance with contractual obligations • Maintain organized and accurate records of audits, quality checks, and related documentation.• Support other aspects of the quality management system as needed• Special projects as assigned.Employee Benefits BCBSL Medical Delta Dental EyeMed Vision 401k Accident & Critical Illness Life Insurance PTO, Holiday Pay, and Floating Holidays Tuition Reimbursement

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! The Quality Assurance Associate, maintains quality standards by performing routine incoming, in process and finished product inspections; approving incoming materials, in-process, and finished products; recording quality results. Enforces compliance with Knipper Quality Policy, SOP's, cGMP, Operations Work Order Instructions, and all safety measures. Full Time 100% On-site Role, Based out of Charlestown, Indiana Must be available to work the hours of 11:30am-8pm ET Monday-Friday. Previous quality assurance experience preferred. Responsibilities Performs incoming material and product inspections (including returned product as necessary) in accordance with documented procedures and sampling plans. Performs line clearance activities in accordance with documented procedures, including assuring that appropriate materials/products are present for a job, paperwork is reviewed and understood, line set-up complies with cGMP and company SOPs; performs first piece inspection for conformance to written specifications (Operations Work Instruction) and sample; documents the results of line clearance inspections performed. Performs random and scheduled inspections of print, assembly and kitting activities in accordance with documented procedures; documents the results of such line inspections when performed. Documents all inspection results by completing reports and logs; verifying same is completed by assembly personnel as required; escalates nonconformance found during incoming inspections accordingly. Maintains safe and healthy work environment by following standards and procedures. Updates job knowledge by participating in educational opportunities; routinely reading standard operation procedures (SOPs), Department Work Instructions (WIs) and Operations Work Instructions. Accomplishes Knipper quality mission by adhering to all quality standards. Reports all concerns and questions to management. Review reconciliation of product and/or components in assembly and fulfillment Reviews and maintains all quality assurance inspection documentation and inspection logs. Reviews and maintains all quality system paperwork involved with incoming inspection, line inspections, return inspections, assembly / production, and distribution activities in conformance with good documentation practices are readily retrievable. May escort vendors for pest control, scale calibration and environmental monitoring. Scope of responsibilities include: RECEIVING; PRODUCTION/ASSEMBLY; MATERIAL AND PRODUCT DESTRUCTION AND RECYCLING; DEA; PRINT This job function has no supervisory responsibilities. The above duties are meant to be representative of the position and not all-inclusive. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Education or general education degree minimum. Preferred: Three months prior QA experience; experience in a regulated industry. KNOWLEDGE, SKILLS & ABILITIES: Good written and oral communication skills. Basic computer knowledge to include: Outlook, Word, Excel, etc. Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent. Ability to carefully monitor activities using as appropriate, instruments, gauges, and processes. Preferred: Working knowledge of current Good Manufacturing Practices. PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 20 pounds. Occasionally lift and/or move objects up to 35 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper Health is an equal opportunity employer.