Quality Assurance Coordinator jobs at Res-Care Premier

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.

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. Trains the project team on their criteria and implementation. Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. Ensures Corporate Quality initiatives and goals are achieved. Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. Reviews utility matrices developed to start up and commission systems and skids. Directs the tracking of deficiencies, test results, or other regularly reported quality control data. Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. Monitors performance of quality control systems to ensure effectiveness and efficiency. Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. Reviews plans and specifications to ensure requirements are met for each construction process. Understand and apply federal, state, and local codes, policies, laws, and regulations. Identifies quality problems or areas for improvement and recommends solutions. Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements B.S. in a Science, Engineering, Construction management, or related field. Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. Proficient skill level in Microsoft Office Suite. Preferred Qualifications First Aid/CPR training. Primavera P6 and MS Project knowledge. Commissioning and System startup experience. Safety You will travel 50% of the time, or as necessary to complete duties. You may be assigned to a client for an extended period of time (1-2 years). OSHA 10 certification (IPS will provide tools) must be maintained during employment. Overnight travel is possible. You will focus on construction field activity and office time will be limited. You will visit Client sites and will be required to adhere to stated safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

STAQ is currently hiring for a Quality Control Manager in the Denver area Monday to Friday, 8 AM to 5 PM Salary: $105K-$110K/year STAQ Pharma is a 503B Outsourcing Facility located in Denver. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ's ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. Roles and Responsibilities Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures. Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B). Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations. Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations. Provide expertise and support to the Operations, Regulatory, and Quality teams. Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring. Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members. Support the batch disposition process including management of reserve samples and QC samples for batch release testing. Manage the budget for the QC Lab department to meet financial objectives. Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc. Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control. Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions. Implement methods of continuous improvement in daily work and in evaluation of company processes and performance. Other duties as assigned. Preferred Qualifications and Education B.S. or B.A. in Microbiology or a closely related field / or equivalent experience. Minimum five (5) years' experience in a quality control environment. Experience in a cGMP pharmaceutical/aseptic manufacturing environment. Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc. Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program. Preferred Experience and Skills Working knowledge of aseptic/sterile manufacturing techniques. Ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills with the ability to interact with all levels across the organization. Demonstrated excellent interpersonal skills and flexibility. Familiarity with 21 CFR Part 11/210/211. Additional Notes Join a dynamic team at the leading edge as we build out a new 137K sq. ft. manufacturing facility. This position will work closely with cross functional teams and report quality data to the department heads for each team, as needed Timeline: We will be accepting applications on an ongoing basis until position is filled.

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.

Sample Coordinator-Full Time About Us: Avara is a dynamic and innovative company dedicated to creating a sense of community through the shared love of fun, accessible, curated fashion that will inspire women to feel authentically confident. Avara creates and curates a line of women's clothing and accessories that come with compliments guaranteed! Avara was founded in 2018 by a mother, Emily Wickard, who after spending 20 years in Corporate Finance, decided to take a leap of faith and start her own clothing brand. Since its humble beginnings in Emily's home, Avara has grown exponentially, with "Avaraistas" in every state and over 130,000 satisfied customers. In 2023, Avara was recognized as the #1 fastest growing privately held eCommerce company in the country by Inc Magazine. Our goal is to be the go-to brand for fun, accessible fashion that allows women to celebrate all of life's moments with confidence and joy. Job Summary We are looking for a hyper-organized self-starter, proactive problem solver, and strong communicator to join us as our Sample Coordinator. This person creates order from chaos, anticipates needs, and ensures our high-volume sample workflow runs seamlessly Key Responsibilities Sample Tracking & Organization Own daily vendor communication and end-to-end tracking and of all Available-to-Ship and Avara Exclusive samples. Maintain accurate, real-time logs of sample status, location, usage, and deadlines. Ensure all incoming samples are properly labeled, tagged, and documented upon arrival. Proactively identify missing, delayed, or incorrect samples and take action to resolve issues quickly. Prepare samples for fittings, photo shoots, line reviews, and assortment showbacks. Vendor Protocol & Compliance Enforce Avara's sample protocol with all vendors, including: Required labeling and style identification Proper packaging On-time delivery Document vendor compliance, send follow-ups, and ensure corrective action is taken when protocol is not met. · Oversee all return shipping of samples, ensuring items are packaged correctly, documented, and delivered back to vendors in a timely and organized manner. Photo Shoot & Creative Coordination Pull, organize, and track all samples used for studio and on-location shoots. After the photoshoot, gather all samples that must be returned and coordinate prompt shipment back to the vendor. Communication & Reporting Provide weekly sample status updates to Buying, Creative, Production, and Leadership. Communicate delays, quality issues, or vendor protocol violations promptly. Serve as the go-to resource for sample location, readiness, and timing. Process Management Maintain a scalable check-in/check-out tracking process for all samples. Identify operational gaps and propose improvements to support the group's growing volume. Support AE development cycles by tracking fit samples, pre-production samples, and finalized AE styles. Skills & Qualifications 1-3 years of experience in operations, coordination, production, showroom support, visual merchandising, or related fields. A proactive problem solver who anticipates needs and prevents issues before they arise. A self-starter with exceptional organization and follow-through. Highly detail-oriented, with the ability to oversee a substantial and ever-changing weekly assortment of samples. Strong communication skills, particularly when enforcing vendor standards. Proficiency in Google Sheets or Excel and Outlook (or similar email application) Ability to lift and move sample bins, garment bags, and boxes (up to ~25 lbs). Comfortable working in a fast-paced environment with frequent new product launches.

This position is responsible for executing and performing multiple cross-functional activities within Isagenix Quality Assurance program which includes functions in document control, quality control, quality assurance incoming product inspections and approvals, as well as product complaints. The position would provide management with briefings and timely reports reflecting the status of documents within a new document control system relevant to current documentation, actively participate in incoming quality assurance inspections, approvals, and rejections, as well as assisting with complaint monitoring and reporting. Work Schedule: This position currently follows a hybrid work model. Employees are required to work from the office at least four days per week (Monday - Thursday), with Friday available for remote work, offering a blend of in-person collaboration and flexibility. Essential Duties & Responsibilities (Other duties may be assigned) * Actively work within the Isagenix Quality Management System (QMS), QualityOne, to support the quality functions in an efficient manner. * Create, review, and revise Isagenix required documentation to ensure compliance to market regulations: FDA 21 CFR 111, 117, and others as applicable. * Escalate any new, unknown product risks or hazards for further evaluation and decisions. * Assist in coordinating and processing finished product master documents for external communication. * Assist with creating, revising, and reviewing SOPs, Process Flow Charts, and other controlled documents. * Track projects, provide updates and provide status reports, as required by management or QA procedures. * Assist with organoleptic evaluations for product qualifications, release samples, shelf-life study samples and taste testing, as needed. * Assist with collecting, reviewing, and organizing information for finished product specifications including analysis of testing methodologies. * Assist with processing laboratory results, data collections, statistical evaluations, trend and prepare quality control reports based on results and data. * Process, coordinate and track internal sample processing and sample submissions to contract laboratories. * Maintain logs (laboratory, tracking, inventory, etc.) and analytical data in an organized, secure manner. * Expand scope of Quality Control by identifying opportunities for improvement and solutions. * May represent QA at company commercialization (POD) meetings, providing status updates on new products and relay all pertinent information to QA team, as needed. * Support other areas or individuals within the Quality department as needed. Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position) * Associate's degree in a fundamental science from an accredited institution or equivalent related experience. * 1 year of analytical food laboratory experience. * Knowledge of dietary supplement and food testing methods. * No dietary restrictions or allergies. Location : Company Overview Established in 2002, Isagenix International has created simple, proven products that optimize what your body is capable of-helping you protect your greatest asset, your health. For more than twenty years, Isagenix has made holistic science an art with transparency and integrity-creating products and systems that address nutrition, stress, fitness, energy, natural beauty, focus, and financial wellbeing. The global wellbeing company, based in Gilbert, Arizona, markets its products through a network of independent distributors in 22 key markets: the United States, Canada, Puerto Rico, Australia, New Zealand, Mexico, the United Kingdom, Ireland, the Netherlands, Belgium, Spain, Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Sweden, and Switzerland. For more information, visit Isagenix.com. Location : EEO Isagenix International, LLC is an equal opportunity employer and affords equal opportunity to all applicants for all positions without regard to race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by law.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: * Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. * Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). * Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. * Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. * Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. * Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. * Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. * Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. * Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: * Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. * Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. * Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. * Skills: * Excellent attention to detail and strong organizational skills. * Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. * Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. * Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. * Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: * Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). * Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Compensation: * $75,000 - $100,000 Schedule: * Monday - Friday 8:00am-4:30pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

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

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures. Key Responsibilities: * Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures. * Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA). * Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits. * Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records. * Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure. * Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable. * Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions. * Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments. * Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements. Qualifications Required Qualifications and Skills: * Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution. * Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control. * Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations. * Skills: * Excellent attention to detail and strong organizational skills. * Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. * Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. * Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. * Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications: * Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification). * Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,) Additional Information Schedule: * Monday - Friday 8:00am-4:30pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:00pm Responsibilities/Essential Duties: Investigations and CAPA Management Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience Bachelor's degree in Life Sciences, Engineering, or related technical field required. Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. Demonstrated expertise in managing deviations and CAPAs, Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-Q10, and relevant USP chapters. Proficiency in root cause analysis tools and Six Sigma methodologies. Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance. Familiarity with data integrity requirements and ALCOA+ compliance. Key Competencies Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification. CAPA Execution: Ensures timely, effective, and risk-based corrective actions. Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems. Collaboration: Works effectively across departments to align investigation outcomes with operational needs. Accountability: Tracks and deliveries on commitments with minimal supervision. Working Conditions: Primarily office-based with routine interaction in manufacturing and laboratory environments. May require off-shift or weekend support during audits, investigations, or operational escalations. Occasional travel may be required for training or supplier quality support Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus Paid time off, holidays, and floating holidays that can be used for whatever you choose Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:00pm Responsibilities/Essential Duties: Investigations and CAPA Management * Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. * Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages * Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. * Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. * Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience * Bachelor's degree in Life Sciences, Engineering, or related technical field required. * Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. * Demonstrated expertise in managing deviations and CAPAs, * Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills * In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-Q10, and relevant USP chapters. * Proficiency in root cause analysis tools and Six Sigma methodologies. * Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance. * Familiarity with data integrity requirements and ALCOA+ compliance. Key Competencies * Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification. * CAPA Execution: Ensures timely, effective, and risk-based corrective actions. * Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems. * Collaboration: Works effectively across departments to align investigation outcomes with operational needs. * Accountability: Tracks and deliveries on commitments with minimal supervision. Working Conditions: * Primarily office-based with routine interaction in manufacturing and laboratory environments. * May require off-shift or weekend support during audits, investigations, or operational escalations. * Occasional travel may be required for training or supplier quality support Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: * Competitive Compensation including base salary and annual performance bonus * Paid time off, holidays, and floating holidays that can be used for whatever you choose * Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job." Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Turning Point Community Programs is seeking a Quality Assurance Coordinator for our Transition Support Services (TSS) North program in Chico. Turning Point Community Programs (TPCP) provides integrated, cost-effective mental health services, employment and housing for adults, children and their families that promote recovery, independence and self-sufficiency. We are committed to innovative and high quality services that assist adults and children with psychiatric, emotional and/or developmental disabilities in achieving their goals. Turning Point Community Programs (TPCP) has offered a path to mental health and recovery since 1976. We help people in our community every single day - creating a better space for all types of people in need. Join our mission of offering hope, respect and support to our clients on their journey to mental health and wellness. GENERAL PURPOSE Under the administrative supervision of the Clinical Director, this position is responsible for ensuring that the program remains in compliance with Regional Center guidelines. Assists the Clinical Director in the quality management functioning of the Program. DISTINGUISHING CHARACTERISTICS This is an at-will administrative position within a program. Additionally, this position is responsible for the day-to-day completion of critical paperwork and assisting the Clinical Director. ESSENTIAL DUTIES AND RESPONSIBILITIES - (ILLUSTRATIVE ONLY) The duties listed below are intended only as illustrations of the various types of work that could be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class Completes Diagnosis updates as assigned. Completes MORS/8 Determinants assessments as assigned. Tracks progress notes and provides feedback directly to management team. Tracks assessments due and completion. Works in coordination with the Team Leaders and Clinical Director to ensure that all assessments and client plans are completed in a timely manner. Attends/Conducts Utilization Review meetings when the Clinical Director is not available. Coordinates with Clinical Director to implement recommendations. Responsible for tracking and reviewing results of internal utilization and review. Reviews charts to ensure that they meet state and legal/Regional Center requirements. Assists the Clinical Director and Program Director with developing the Quality Improvement plan and implementing changes. Assist the Clinical Director with filing, organizing and maintaining a record of KETs (Key Event Tracking) and inputting data into charted system. Assist the Clinical Director with filing, organizing and maintaining a record of Risk Management Binder (SIRs). In coordination with the Clinical Director and Program Director, reviews and evaluates customer satisfaction/performance outcome data. Ensures the safety, health, and well-being of the members. Completes paperwork as assigned in a timely manner. Meets the standards set for performance in all aspects of job duties. Provides support to other staff members as needed. Adheres to and upholds the policies and procedures of Turning Point Community Programs. Attends staff meetings unless approval for non-attendance is secured from the Clinical Director or Program Director. Schedule: Monday - Friday, 8:30 am - 5:00 pm Compensation: $26.00 - $27.59 per hour Interested? Join us at our open interviews on Wednesdays from 2-4PM, located at 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA 95670 -or- CLICK HERE TO APPLY NOW!

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.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

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.

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: * Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. * Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. * Perform and verify daily verification data for accuracy and completeness before submitting it for review. * Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. * Train new peers in LIMS operations, including sample manager and resource modules. * Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: * Performs other functions as required or assigned. * Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. * Must understand and apply cGMP requirements applicable to quality control laboratory. * Follow up on sample status and testing progress within the LIMS system. * Participate in continuous improvement initiatives to optimize LIMS functionality and workflows.

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. Perform and verify daily verification data for accuracy and completeness before submitting it for review. Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. Train new peers in LIMS operations, including sample manager and resource modules. Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: Performs other functions as required or assigned. Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. Must understand and apply cGMP requirements applicable to quality control laboratory. Follow up on sample status and testing progress within the LIMS system. Participate in continuous improvement initiatives to optimize LIMS functionality and workflows. Education: Associate Degree - Required Bachelors Degree (BA/BS) Chemistry or related field - Preferred Experience: 1 year or more in Pharmaceutical/manutfacturing Skills: Proficient in laboratory informatics - Intermediate Strong understanding of regulatory compliance (FDA, GMP). - Intermediate Proficiency in inventory management systems and data analysis tools. - Intermediate Excellent organizational, communication, and problem-solving skills. - Intermediate The hourly rate for this position ranges from $22.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.