Quality assurance specialist jobs in Santee, CA

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (*************** Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (**************** with a mission to provide the highest quality materials to niche life science markets worldwide. Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer. Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more. JOB SUMMARY: Under strategic leadership, sustain the improvement of the Quality Management Systems (QMS) and manages the development of quality assurance & systems staff. Utilize the following industry standards to drive high-quality products: Current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Organization for Standardization (ISO). Facilitate employee relations issues including coaching, mentoring, and disciplining including performance evaluation of employees. Provides strong leadership to motivate, guide and inspire employees to meet the organization's business objectives with production. Lead the implementation phase of MasterControl, ensuring successful implementation, and post-implementation management. ESSENTIAL DUTIES and/or RESPONSIBILITIES: Partners with leadership to develop the Quality Management System (QMS) and ensure it is compliant with relevant regulations, including ISO 9001, 21 CFR Part 210 and 211, ICH, and other applicable national and international regulatory guidelines.Ensure the QMS always remains in an auditable state. Oversees the daily operations of the QMS, ensuring it runs efficiently and in compliance with quality standards. This includes managing critical quality systems processes such as Incoming Raw Material Receipt, Raw Material Review/Disposition, Final Product Review/Disposition. Manages quality events and investigations including but not limited to Deviations, CAPA, Change Control, OOS, OOT, Customer Complaints, including leading and facilitating cross-functional meetings to ensure proper assessments and actions. Ensures QA review of Validation/Qualification activities including protocols, execution, and reports. Upholds timely response to events and on-the-floor QA support(MQA), including ensuring the MQA program is tracked and measurable. Leads the transition of QMS programs, such as Quality Events (Deviation, CAPA, Change Control, OOS, OOT), Audits and Supplier Qualification transition into Master Control, and serves as the System Administrator. Administers post-implementation management of MasterControl, including, but not limited to, system optimization, performing troubleshooting support, managing software updates, and continuously improving system functionality to meet evolving regulatory needs. Reports key metrics for QA Operations turnaround times and Quality Events. Contributes to the continuous improvement initiatives related to the QMS, collaborating with cross-functional teams to optimize quality processes. Analyze quality data and metrics to identify trends, root causes, and areas for process improvement within manufacturing and quality control activities. Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards. Supervises and develops a team providing guidance, training, and support to ensure compliance with regulatory standards and best practices. Mentors and develops a team of the QA team, fostering an environment of accountability and growth. Ensures cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations. Facilitates training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce. Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team. Conducts performance reviews for direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations. Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis. SUPERVISOR RESONSIBLITIES: Quality Assurance Associate Quality Assurance Specialist Sr. Quality Assurance Specialist MINIMUM EDUCATION and/or EXPERIENCE: Bachelor's degree in a scientific discipline; and five (5) years' directly related experience in a Good Practice (GXP) or ISO manufacturing-controlled environment or equivalent combination of education and experience. Experience in transitioning from paper based to electronic QMS. KNOWLEDGE, SKILLS and/or ABILITIES: Working knowledge of pharmaceutical industry concepts, as well as analytical methods and writing skills, including documenting manufacturing processes, a plus. Familiarity in Lean or Six Sigma, a plus. Strong Knowledge of quality management principles and practices, including ISO 9001 and cGMP standards. Proficient in the use of quality management software with experience in implementing or managing MasterControl being highly desirable. Experience conducting technical investigations with formal root cause analysis tools. Prior supervisory experience, preferred. Knowledgeable of change control, validation/qualification, and method development and tech transfer. Strong knowledge of formal root cause analysis and risk assessment tools. Ability to lead or facilitate investigations and/or risk assessments. Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. Strong ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution, including communicating with equipment suppliers to obtain input on equipment modification and improvement. Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, LIMS, and Familiarity with statistical analysis tools. Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations. Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public. Work independently as well as in a small and/or large group and foster cooperation in a team environment using interpersonal skills to document working knowledge. Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills. CERTIFICATES and/or LICENSES: American Society for Quality Certified, a plus. Certified Quality Engineer, a plus. Certified Quality Auditor, preferred. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Works in a typical office environment with prolonged periods in front a computer entering or researching data. Regularly required to sit; use hands to finger, handle or feel and talk or hear. Availability and willingness to travel if required for audits, inspection, vendor management or if requested to visit or attend a business transaction as legal agent of the company. Must be able to work extended hours per the demands of the business.

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). Collect site metrics for selection of investigator site audits while analyzing and reporting trends. Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. Provide QA support for clinical study programs with GCP compliance, as needed. Assist during health authority inspections, including document management and logistical coordination. Support and contribute to risk management analysis efforts associated with GCP functions. Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Facilitate ongoing quality improvement through communication of audit results and CAPAs Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). Keep up to date with all related quality legislation and compliance issues. Requirements: Bachelor's degree in a science discipline is required. 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. 2 years of relevant experience in GxP function providing Quality and Compliance oversight. Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. California pay range $80,000-$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

IPS - MAST Technologies is seeking an experienced AS9100 QA Specialist to join our Quality team. This individual will play a key role in maintaining and improving MAST Technologies' AS9100D-certified Quality Management System, ensuring compliance with customer, regulatory, and internal requirements. The ideal candidate will have a strong background in aerospace or defense manufacturing and a hands-on approach to quality assurance. Position Summary: The Quality Assurance (QA) Specialist is responsible for ensuring that all products, processes, and documentation meet internal standards, customer requirements, and applicable regulatory/industry guidelines (AS9100, ISO 13485, etc.). This role supports day-to-day quality system activities, conducts audits, facilitates corrective and preventive actions, and partners closely with operations, engineering, and supply chain teams to maintain a culture of compliance and continuous improvement. About IPS: Integrated Polymer Solutions (IPS) is a leading developer and manufacturer of advanced materials and engineered components, specializing in high-value end markets such as aerospace, defense, medical, semiconductors, robotics, energy, and industrial applications. IPS is comprised of 10 highly respected brands, each recognized for their expertise and innovation: AkroFire, ABBA Roller, Icon Aerospace Technology, IRP Medical, MAST Technologies, Northern Engineering Sheffield (NES), Rubbercraft, Swift Textile Metalizing (STM), RMB Products, and SPIRA Manufacturing. Our extensive product portfolio includes elastomeric seals, gaskets, tooling, hoses, ablatives, survivability tiles, coatings and tapes, EMI and thermal shielding, electrically conductive metalized fabrics, and encapsulated O-rings-all designed to meet the most demanding performance requirements in mission-critical applications. Job Accountabilities: Quality System Management Support maintenance and continuous improvement of the Quality Management System (QMS). Preferable AS9100 Assist with document control, change management, training, and compliance recordkeeping. Support daily operations in maintaining compliance with AS9100D and ISO 9001 standards across all functions. Auditing & Compliance Conduct internal audits to verify compliance with AS9100, ISO, and customer requirements. Support customer and third-party audits by preparing documentation and ensuring timely responses to findings. Plan, conduct, and document internal QMS audits; support external and customer audits. Maintain accurate and compliant quality records, procedures, and work instructions through the document control system. Corrective & Preventive Action (CAPA) Initiate, investigate, and track nonconformances and CAPAs through closure. Analyze root causes and work cross-functionally to implement effective corrective actions. Inspection & Testing Support and Shipping Provide guidance and oversight to incoming, in-process, and final inspection activities. Ensure test and inspection records are accurate, complete, and properly maintained. Interface with customers on quality issues, support customer satisfaction metrics, and evaluate supplier performance and incoming inspections. Monitor and manage nonconformance reports (NCRs), Material Review Board (MRB) processes, and disposition activities. Continuous Improvement Partner with operations to drive process improvements that enhance quality, reduce cost, and improve efficiency. Assist in quality metrics reporting and trending analysis to identify improvement opportunities. Collaborate with Engineering and Production to drive continuous improvement through Lean, Six Sigma, or other methodologies. Training & Communication Support employee training on quality policies, procedures, and compliance requirements. Communicate quality expectations clearly across teams to reinforce accountability. Support company-wide training on quality procedures and AS9100 awareness. Shipping & Logistics Prepare, package, and ship products in accordance with customer specifications, export regulations (including ITAR/EAR), and AS9100 traceability requirements. Ensure all shipping documentation (COCs, packing slips, labels, invoices) is complete and accurate. Coordinate with internal teams to ensure timely shipment of products. Maintain shipment records for traceability, quality, and audit purposes. Conduct final visual inspections and packaging inspections to verify product integrity and conformance before shipment. Support on-time delivery performance metrics and improvement efforts. Maintain shipping supplies and inventory of packaging materials. Job Specifications: Education: Bachelor's degree in Quality, Engineering, Life Sciences, or related field preferred; equivalent experience considered. Years' Experience: 4-5 years of experience in Quality Assurance or Quality Control, ideally in aerospace, defense, or medical device manufacturing. Skills: Working knowledge of quality standards and regulations (AS9100, ISO 9001, ISO 13485, ITAR). Strong analytical, problem-solving, and root-cause analysis skills. Proficiency with MS Office and QMS software; experience with ERP/MRP systems preferred. Excellent attention to detail, organizational skills, and ability to manage multiple priorities. Effective communication skills with ability to interact across functions and levels Upholds standards and regulations with consistency. Works effectively with cross-functional teams to solve problems. Seeks ways to optimize processes and eliminate waste. Maintains accuracy and focus in a dynamic, fast-paced environment. Benefits: At Integrated Polymer Solutions, we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work. IPS is an Equal Opportunity Employer Veterans/Disabled - Affirmative Action Employer. This position requires using information subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee. (Actual placement within the salary range is dependent on multiple factors, including but not limited to skills, education, experience and location)

About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK , is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit ****************** Job Summary: This position is responsible for cGMP auditing and supplier management activities at Artiva. Duties/Responsibilities: Perform GMP/GDP audits in accordance with the external and internal audit program. Support GXP audits (GLP, GCP, GCLP), as necessary. Perform Drop-In GMP Internal audits. Create and maintain audit schedules. Track audit responses to completion. Oversee and maintain the supplier qualification program. Support the creation and execution of Quality Agreements with suppliers. Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities. Support audits by regulatory or state agencies and partners. Support QA review of Analytical Development and Process Development data and reports, as needed. Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures. Support other QA department needs as identified by management. Requirements: Bachelor's degree or a combination of relevant education and applicable job experience 5+ years' experience in an FDA regulated industry and expert knowledge of CGMP regulations Certified Quality Auditor credential is a plus. Ability to adapt quickly to shifting needs and/or priorities Able to interface well with all levels of personnel Excellent communications skills, both written and verbal and a high degree of professionalism Exceptional attention to detail Flexibility to travel Why you should apply: We have a fantastic team and philosophy! We are passionate - we deeply care about our team, our science, and improving the lives of patients. We are tenacious - laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: · A beautiful facility · An entrepreneurial, highly collaborative, and innovative environment · Comprehensive benefits, including: Medical, Dental, and Vision Group Life Insurance Long Term Disability (LTD) 401(k) Retirement Plan with match Employee Assistance Program (EAP) Flexible Spending Account (FSA) Paid Time Off (PTO) Company paid holidays, including the year-end holiday week Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $100,000 - 120,000. Exact compensation may vary based on skills and experience.

Job Purpose/Summary This position will be responsible for supporting and assisting with the management and maintenance of the site-wide quality program, as well as the EHS program. The program is designed to ensure continuous measurement and improvement in site quality, compliance and overal performance. This position is responsible for overseeing key quality program elements such as, document control, internal facility audits, data and report audits, deviation, investigations, CAPA and general facility and/or study events. The employee will work to ensure the consistency, reproducibility, quality and integrity of operations in line with Crown programs. The position will employ effective tools to support risk mitigation of quality deviations and to respond to quality deviations implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulations governing the sites operations. The success of the role will be measured by continuous improvements in site quality, compliance and efficiency of operation, meeting or exceeding client expectations and corporate goals and objectives. Essential Functions/Responsibilities * Support and assist with the management and maintenance of the site-wide quality program, including GLP/GCLP/ISO9001/CLIA/CAP requirements for pre-clinical and clinical operations, as applicable. * Conduct routine internal audits of the animal vivarium, in-vitro and biomarker laboratories * Manage document control in EQMS * Assist with the site training program. * Provide support for internal/external complaint and deviation investigations. * Support study directors to develop Corrective Action Preventive Action (CAPA) plans. * Support the various site continued improvement efforts. * Lead site internal audits to ensure compliance to QMS * Support client audit and supplier qualification program. * Represent QAU on the site EHS (Environment, Health and Safety) team * Monitor site key performance indicator (KPI) and provide reports for management review * Actively contribute to the success of the overall QA team and the site as a whole. Minimum Requirements * Requires a Bachelor degree in a technical field, or equivalent combination of academic and work experience. * Requires 2+ years of auditing and document control within a regulated environment * Able to interpret analytical data to support decision-making * Able to communicate in a clear, coherent and concise manner (verbal and written communication) * Willing and able to work independently and in a team environment to efficiently meet assigned timelines * Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and Internet * Excellent interpersonal, organizational and time-management skills * Able to multi-task with a high degree of professionalism and diplomacy Preferred Requirements * Laboratory working experience in regulated environment is preferred * Experience working with an EHS is team preferred * Experience with AAALAC/IACUC is preferred * Experience with Veeva Vault e-QMS and IDBS ELN systems is preferred The California salary range for this position is: $78,795.00 - $92,700.00 This salary (or salary range) is merely an estimate and may vary based on an applicant's skills and prior relevant experience. Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Trammell Crow Residential (TCR) is a leading multifamily real estate developer with a local presence in 17 key U.S. markets. Over 40 years, TCR has built more than 272,000 premier multifamily residences, delivering amenity-rich communities in economically thriving locations nationwide. TCR is part of the development platform of Crow Holdings, a privately owned real estate investment and development firm with nearly 75 years of history, $30 billion of assets under management, and an established platform with a vision for continued success. For more information, please visit ********************* Position Summary Trammell Crow Residential seeks a Quality Assurance Manager for Carlsbad, CA. The role is responsible for coordinating TCR development and quality directives by performing as an Owner's Field Representative for the TCR Senior Managing Director/Managing Director of Multi-Family Development. Primary Responsibilities Manages Quality Assurance in day-to-day operations for his or her job duties Coordinate all plan reviews and field inspections with consultants including Accessibility, Third Party Architectural, Waterproof, Tyvek (or other WRB) Environment/AQI and Acoustical Initiate, execute, implement and track plan and site inspections for all Division projects Maintains contact with Superintendents, Project Managers, and QA Specialists on schedule changes and turn dates for up to four projects simultaneously Responsible for monthly QA documentation project inspection walks with published report Responsible for acceptance of new residential construction buildings and property from Construction division and coordinating/aligning with Asset Management. Manages third party quality inspections, if used Coordinate all plan reviews and help monitoring field inspections with consultants including FHA/ANSI-ADA Accessibility, Third Party Architectural, Fa, Waterproof, Environment/AQI and Acoustical, etc Oversee all details within the boundaries of the new property and ensure quality standards set forth by the Division's Senior Managing Director and Construction President are maintained for all TCR properties Coordinate with 3rd party Property Manager and Construction Superintendent or Project Manager to ensure all warranty and construction quality deficiency issues are addressed Work closely with third party safety consultant to make observations and recommendations on safety for all persons and matters related to the property and TCR Construction projects Monitors periodic and due-diligence inspections, assist with recommendations and resolutions. Reviews capitol project contracts prior to signing, with recommendations that address products to be furnished and safety practices while work is being executed Presents and review TCR quality standards to new employees within the construction group Works as the main point of contact for WRB manufacturer inspections, to include mock-up reviews and pre- construction meetings / final closeout of field inspection reports and warranty Work with Development and Asset Management maintaining developed properties and help prepare for sale Desired Skills & Experience Bachelor's degree in business, management or related field required 5+ years of related experience in construction procedures, trade practices, materials, means and methods, building codes, project scheduling, and safety procedures Familiarity with federal and local municipal/regulation codes OSHA Certification required; MS Office knowledge preferred. Proficient in Info Path and MS Office 365, Excell, Blue Beam, Word, Procore Excellent customer service and interpersonal skills; Professional verbal and written communication skills. Strong organizational and time-management skills, achieving project deadlines

The QA Specialist II performs the day-to-day activities of the QA department to ensure drug substances manufactured by Bachem comply with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial purposes. Individuals in this position review and process assigned GMP documents, provide cGMP guidance to other departments, and provide support to customer and regulatory audits. Additionally, to manage (i.e. reconcile, issue, and maintain) GMP documents and records and, to provide support in document management electronic systems (e.g. MasterControl) What you will do * Performs production room, dispensary and shipment clearance verifications, as required * Revises established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned. * Manages GMP documentation and their workflows as required by the department * Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving * Coordinate, review and approval of quality events * Training of new hires * Provides support to regulatory, customer, and internal audits * Drives continuous improvements and represents QA in process improvement project teams * Implements and maintains Quality Management System. * Scan, verify and archive GMP records (internal and external). * Review and/or approval of monitoring / trending data * Represent QA in project teams (e.g. - harmonization of systems / processes across Bachem sites, implementation of new systems / processes) Qualifications * Bachelor's degree in a science related field and a minimum of 3 years' experience in a GMP manufacturing setting or * Associates in a science related field and a minimum of 5 years' experience in the GMP manufacturing setting * 3-5 years' experience in Quality Assurance and/or Quality Control * 3-5 years' experience in internal auditing as well as working with regulatory agencies * 3-5 years' experience working in ISO 7 and ISO 8 control environment and support real time batch record review * Ability to review scans of BPRs and chromatograms with high accuracy * Knowledge of cGMP and FDA regulations and guidance(s) * Knowledge of Quality Management Systems * Knowledge of GxP * Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint * Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues * Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment * Ability to work independently and manage one's time * Communicate effectively and ability to function well in a team environment * Ability to troubleshoot and resolve problems Base Salary Range: Specialist II: $71,856 - $98,857 Specialist III: $79,904 - $109,868 Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. Please note: unsolicited resumes from recruitment agencies will not be considered. Share this job posting by email

Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women's health. We achieve this by fulfilling our promise to bring The Science of Sure to life. The Post Market Quality Assurance (QA) team plays a critical role in safeguarding patient safety and ensuring regulatory compliance across global markets for Hologic Molecular Diagnostic products. Think this role is for you? As a Quality Assurance Specialist 1 under the Post-Market QA team, you will play a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release. You will be responsible for monitoring and facilitating post-market complaints, ensuring compliance with applicable industry regulations, standards, and company policy. Success in this role requires strong analytical skills, attention to detail, and effective collaboration with cross-functional teams to resolve issues of limited complexity and drive continuous improvement. Key Outcomes Complaint handling and investigation Receive, document, and process product complaints in compliance with applicable regulatory requirements and company standard operating procedures (SOPs). Conduct initial assessment of complaints. Regulatory reporting Identify and escalate potential adverse events to QA management. Support preparation and submission of regulatory reports according to global regulatory requirements under supervision of Senior QA Specialists or management. Ensure post-market activities are compliant. Data analysis and trending Assist with complaint metrics and basic trend analysis. Perform complaint-related queries as needed. Audit and inspection support Support internal and external audits related to post-market surveillance and complaint handling as needed. Maintain accurate and audit-ready documentation. Training and process development Contribute to the development and improvement of SOPs, and other materials related to post-market quality assurance under the supervision of Senior QA Specialists or management. Do you have what it takes? You are a good communicator, have impeccable attention to detail, and strong organizational and documentation skills. You work well in a cross-functional team environment, can work independently, and have a proactive mindset. You have strong analytical and problem-solving skills and are comfortable presenting data. Additional qualifications and information Bachelor's degree in Engineering, Quality, Life Sciences, or related field, or equivalent experience. 0-2 years of experience in post-market quality assurance within the medical device industry is highly preferred. Knowledge of post-market surveillance, complaint handling, and regulatory reporting requirements (e.g., ISO 13485, FDA 21, CFR 820, EU, MDR). Certification in Quality or Regulatory (ASQ, RAPS) is a plus ---- The annualized base salary range for this role is $70,500 - $71,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-EK1

Acuity Inc. (NYSE: AYI) is a market-leading industrial technology company. We use technology to solve problems in spaces, light and more things to come. Through our two business segments, Acuity Brands Lighting (ABL) and Acuity Intelligent Spaces (AIS), we design, manufacture, and bring to market products and services that make a valuable difference in people's lives. We achieve growth through the development of innovative new products and services, including lighting, lighting controls, building management solutions, and an audio, video and control platform. We focus on customer outcomes and drive growth and productivity to increase market share and deliver superior returns. We look to aggressively deploy capital to grow the business and to enter attractive new verticals. Acuity Inc. is based in Atlanta, Georgia, with operations across North America, Europe and Asia. The Company is powered by approximately 13,000 dedicated and talented associates. Visit us at ***************** . **Job Summary** Create accurate Bill of Materials and assembly drawings for our ERP system that informs the Manufacturing and Assembly teams what to fabricate and how to assemble the product. This is a full-time position, and hours of work and days are varied. Ability to work Monday through Friday (6:30 A.M - 3:30 P.M., 7A.M -4P.M.) Occasional evening and weekend work may be required as job duties demand. **Key Tasks & Responsibilities (Essential Functions)** + Interpret and create drawings for simple to complex product and assembly drawings in order to make accurate BOMs. + Creation of BOMs and drawings for individual parts, sub-assemblies and finished products. + Modify/Update existing BOMs to meet the needs of new specific requirements. + Develop drawings for new custom parts needed in the BOMs. + Work collaboratively with Engineering and Design Assist Departments. + Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. **Experience (minimum experience required)** + Proficient knowledge working in Windows environment and software related (Outlook, Office, etc.). + Knowledge of engineering Solid works software. + Knowledge and understanding of the concept of Bills of Materials and how they are built. + Ability to learn new software and processes. + Ability to read and interpret drawings and diagrams. + Ability or willingness to learn how to analyze parts, assemblies, and production processes. + High capacity to work in a focused and methodical manner. + High capacity to work under pressure and fulfill tight deliver schedules. + Comfortable working on highly focused tasks. Computer program knowledge should include the following, but training is available for the right candidate: + MS Office (excel, PowerPoint, Word), SharePoint + SolidWorks + Adobe Illustrator & Photoshop (preferred but not essential) **Education** + Minimum - High School Diploma with 1-2 years of drafting technician experience. + College or Associate Degree manufacturing or drafting technical education preferred. **Preferred Experience (i.e., industry experience)** Highly proficient in the use of PC and software related to engineering: + 3D modeling + 2D technical drawing + Data base drawing management + The candidate must be a fast learner with excellent retention of knowledge and details **Physical Requirements** + Light Work **Work Environment** + This position is within a professional work environment. + This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. + The employee is exposed to a variety of extreme conditions that may be found while walking the production floor. + No travel will be required for this position. \#LI-EG1 **The range for this position is $36,000 to $64,800. Placement within this range may vary, depending on the applicant's experience and geographic location. Acuity offers generous benefits including health care, dental coverage, vision plans, 401K benefits, and commissions/incentive compensation depending on the role. For a list of our benefits, click** **here** **.** We value diversity and are an equal opportunity employer. All qualified applicants will be considered for employment without regards to race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, covered veteran status, protected genetic information, or any other characteristic protected by law. Please click here (**************************** and here (************************************************************************************************** for more information. Accommodation for Applicants with Disabilities: As an equal opportunity employer, Acuity Inc. is committed to providing reasonable accommodations in its application process for qualified individuals with disabilities and disabled veterans. If you have difficulty using our online system due to a disability and need an accommodation, you may contact us at **************. Please clearly indicate what type of accommodation you are requesting and for what requisition. Any unsolicited resumes sent to Acuity Inc. from a third party, such as an Agency recruiter, including unsolicited resumes sent to an Acuity Inc. mailing address, fax machine or email address, directly to Acuity Inc. employees, or to Acuity Inc. resume database will be considered Acuity Inc. property. Acuity Inc. will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Acuity Inc. will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor, but does not have the appropriate approvals to be engaged on a search. E-Verify Participation Poster (******************************************************************************************** e-verify.gov eeoc.gov (**********************************************

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.

Veteran Firm Seeking a Software Documentation Specialist for an Onsite Assignment in San Diego, CA My name is Stephen Hrutka, and I lead a Veteran-owned consulting firm in Washington, DC, focused on strategic sourcing, supply chain, and IT Staffing. We are seeking to fill the Software Documentation Specialist role for an innovative rail engineering solutions provider and systems integrator company. The ideal candidate is a San Diego resident with 4-6 years of experience in technical documentation, and proficiency with document management tools. If you're interested, I'll gladly provide more details about the role and further discuss your qualifications. Thanks, Stephen M Hrutka Principal Consultant *************** Executive Summary: HRUCKUS is looking for an experienced Software Documentation Specialist to support a client's technical delivery and services teams by creating, managing, and maintaining all technical documentation for their software products. Essential Job Functions/Responsibilities: * Developing user manuals, technical specifications, test plans and online help content to ensure clarity and accessibility * Organization and maintain company's documents, including cataloging * Collaboration with engineers, product managers and other team members to gather information and ensure accuracy * Manage documentation projects from inception to completion, including planning, scheduling, and tracking progress to meet deadlines * Proactively identifies documentation needs, proposes improvements, and takes ownership of content creation and maintenance processes. Position Requirements: * Bachelor's degree in Technical Communication, or a related field * 4-6 years of experience in creating technical documentation, including test plans and software development guides. * Ability to communicate clearly, both orally and in writing * Strong organizational skills * Proficiency in document management tools Position Details: * This is an onsite role in San Diego, CA. * This position will report primarily to a Sr. Director of Engineering and interface with multiple managers across technical delivery and services teams. * Salary range is from $82,000 to $85,000 annually.

General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We have an exciting opportunity for an Information Systems Security Officer (ISSO) to join our Classified Systems team in San Diego (Poway), CA. With general supervision, this position is responsible for participating in monitoring, evaluating and administering system compliance with information technology (IT) security requirements to ensure company, regulatory and customer requirements are met. DUTIES AND RESPONSIBILITIES: interprets regulations as they apply to information systems, platforms, and IT operating processes, practices and procedures. Participates in the development or modification of the computer environment information assurance security program plans and requirements. Participates in the development, distribution, and maintenance of System Security Plans, instructions, guidance, and standard operating procedures. Participates in audits of IT, platforms, and operating procedures; analyzes results. Participates in identifying risks and makes recommendations for improvements; may participate in corrective measures when incidents or vulnerabilities are discovered. Maintains knowledge of applicable policies, regulations, and compliance documents related to classified computing assets and environments. May represent the organization as a primary contact with internal representatives. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Typically requires a bachelors degree in a related discipline and six or more years of progressive professional experience in information assurance or a related field. Equivalent professional experience may be substituted in lieu of education. Must possess an active Secret clearance and have the ability to obtain and maintain a TS (with SAP & SCI eligibility). Must maintain DoD 8570 IAM Level I (e.g. Security +) professional certification as required by customers or contractual obligations. Security + certification required. Experience with DoD policy such as Risk Management Framework and Joint SAP Implementation Guide. Operational experience with installing, troubleshooting, and auditing Windows desktop & server operating systems. Experience with DISA STIGs, SCAP tool, ACAS. Experience installing and troubleshooting common x86-based computer hardware. Must demonstrate a general understanding of information assurance principles, theories, concepts and techniques. Must have experience organizing, planning, scheduling, conducting, and coordinating work assignments to meet project milestones or established completion dates. Must possess the ability to understand new concepts quickly and apply them in an evolving environment while contributing to the development of new processes. Must be customer focused and possess: The ability to identify issues, analyze data and develop solutions to a variety of problems. Good analytical, verbal and written communication skills to accurately document, report, and present findings. Good interpersonal skills enabling an effective interface with other professionals; and good computer skills. Ability to work independently or in a team environment is essential as is the ability to work extended hours as required.

Cooley is seeking a Document Specialist to join the Document Processing team. The Document Processing Specialist is responsible for providing document production and processing support.The Document Processing Specialist will work together with other document processing specialist and/or proofreader team members across both domestic/international locations and schedules in an effort to provide the highest level of customer service and quality in an effort to provide the highest level of customer service and quality. Responsibilities include, but are not limited to the following: Schedule for Work Week : Sunday-Thursday: 10:00 PM-6:30 AM (Pacific Time) Friday: OFF Position responsibilities: Create new documents and revise existing documents in Microsoft Word, Excel, PowerPoint, and Visio using conversion of electronic file or new input typing, or by downloading and reformatting documents from Internet resources such as EDGAR databases Reformat existing documents into Cooley templates and standard or custom formats Convert documents to Word, Excel, PowerPoint and Visio from a variety of applications and file formats, such as pdf Transcribe analog or digital dictation files Proofread all edits made or word-for-word for new input, or conversion projects for accuracy Troubleshoot issues in multiple software applications, including Word, Excel and PowerPoint Answer hotline calls, proxy on to user workstations and respond and resolve user document and software issues Create fill-in forms in Acrobat Create charts, graphs, tables and spreadsheets as requested Use email, including email with multiple attachments Transfer documents to/from secure file transfer platforms Conduct Internet, intranet, network and archive searches, as requested Download/Save/Print to PDF from various Data Sites Mark and generate Table of Contents and Table of Authorities (utilizing Best Authority) Perform redlines using Litera Compare and native Word Log work and cost recovery information All other duties as assigned or required Skills & experience: Required: After orientation at Cooley LLP, exhibit proficiency in the Microsoft Office suite, iManage and other firm applications Available to work overtime and flexible schedule, as required Knowledge of Microsoft Office Suite, iManage, Visio, Acrobat, IntApp, eDictation, Litera, Compare and Best Authority Fast and accurate typing General understanding of personal computers Previous experience supporting multi-locations and time zones Previous legal document processing experience 1. Document Specialist I: Minimum 1+ year prior document processing experience 2.Document Specialist II: Minimum 5+ years prior document processing experience with proven software knowledge and document expertise Cooley offers a competitive compensation and excellent benefits package and is committed to fair and equitable employment practices. EOE. The expected hourly pay range for this position with a work schedule of 40 hours per week is $32.00 - $56.50 ($66,560.00 - $117,520.00 annually). Please note that final offer amount will be dependent on geographic location, applicable experience and skillset of the candidate. We offer a full range of elective benefits including medical, health savings account (with applicable medical plan), dental, vision, health and/or dependent care flexible spending accounts, pre-tax commuter benefits, life insurance, AD&D, long-term care coverage, backup care for children and/or adults and other parental support benefits. In addition to elective benefit options, benefited employees receive firm-paid life insurance, AD&D, LTD, short term medical benefits as well as 20 days of Paid Time Off (“PTO”) and 10 paid holidays each year. We provide generous parental leave and fertility benefits. New employees will attend a detailed benefit orientation to learn more about our many benefits and resources.

There's something truly fun and exciting about Hilton Grand Vacations. Our inspiration drives us in making a positive impact and memorable experiences for our owners, team members and guests. HGV Team Members are at the center of everything we do and it's their talent, passion, and dedication that drives our success! Quality Assurance is the primary liaison to the customer and handles the customer follow-up process. Here's why you'll love it here! Excellent health care options (medical, dental, and vision) 401(k) with Employer matching Employee Stock Purchase Program Paid Time Off (PTO) that allows for adventure, rest, relaxation or recuperation. The industries top training in a lively environment Our Go Hilton Team Member Travel Program offers Team Member and family travel discounts Perks at Work Discount Program $31.24 per hour And so much more! Hilton Grand Vacations is a leader in the vacation ownership industry, operating with an unwavering commitment to innovation, quality, and continued growth. At the core of our company's success are our Team Members. To fulfill this role successfully, you must possess the following minimum qualifications and experience: High School Diploma/GED or equivalent experience Have open schedule to work weekends and holidays Current CA notary public or ability to obtain within 90 days Current California Real Estate License or willing to do the coursework and pass the test to get licensed within 6 months 1-3 years of related experience It would be advantageous in this position for you to demonstrate the following capabilities and distinctions: Associate's Degree/College Diploma When you join Hilton Grand Vacations, you join a group of Team Members dedicated to helping Owners and Guests around the world make every vacation they take a memorable one. Hilton Grand Vacations is a leading vacation ownership company bringing our Guests vacation dreams to life. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Responsibilities: Provide professional and courteous service to all owners and guests in accordance with HGVC's standards of integrity and quality service Provide excellent service to guests and new owners from the date of purchase until the time their membership account has been established. Manage and build reports Keep up with materials that need to be ordered. Ensure compliance standards are being met Meet with current owners at the Sales Gallery and resolve any issues they may have

Required Skills: - 4-6 years of experience in creating technical documentation, including test plans and software development guides. - Ability to communicate clearly, both orally and in writing - Proficiency in document management tools - Developing user manuals, technical specifications, test plans and online help content to ensure clarity and accessibility Organization and maintain company's documents, including cataloging - Collaboration with engineers, product managers and other team members to gather information and ensure accuracy - Manage documentation projects from inception to completion, including planning, scheduling, and tracking progress to meet deadlines - Proactively identifies documentation needs, proposes improvements, and takes ownership of content creation and maintenance processes.

AdaptHealth Opportunity - Apply Today! At AdaptHealth we offer full-service home medical equipment products and services to empower patients to live their best lives - out of the hospital and in their homes. We are actively recruiting in your area. If you are passionate about making a profound impact on the quality of patients' lives, please click to apply, we would love to hear from you. Documentation Specialist Documentation Specialists creates and generates electronic forms requesting patient documents from physicians and insurances, as well as collect and manage patient eligibility documents. Additionally, responsible for maintaining a timely revenue cycle for all the goods and services provided by AdaptHealth. Job Duties: Create and generate electronic forms requesting patient documents from physicians. Collect and manage patient eligibility documents such as prescriptions, certificates of medical necessity, letters of medical necessity and prior authorizations. Contact doctor offices as necessary to collect prescriptions, certificates of medical necessity, letters of medical necessity, clinical notes, and lab results. Contact insurance companies to collect approved prior-authorization requests. Escalate recurring problem accounts or physician groups or other trends to the management appropriately and in a timely manner. Maintain regular, predictable, consistent attendance and flexibility to meet the needs of the department. Understand and follow all Medicare, Medicaid, HIPAA, and Private Insurance regulations and requirements. Plan and organize work effectively and ensure its completion. Meet all productivity requirements. Demonstrate team behavior and promote a team-oriented environment. Actively participate in continuous quality improvement. Always represent the organization professionally. Serve as backup to Customer Service department for customer concerns, issues, complaints, or questions. Analyze documentation required for billing services and ensure compliance to payer requirements. Resolve pending revenue by reconciling received documentation and pending charges. Collaborates with physician offices, AdaptHealth sales and support staff to ensure timely receipt of documentation. Identify trends and providing feedback and education to internal and external customers on compliant documentation requirements for services provided. Requests authorization from state Medicaid programs. Maintains and updates physician databases to ensure accurate delivery of billing documentation and communications with physician offices. Competency, Skills and Abilities: Decision Making Analytical and problem-solving skills with attention to detail Strong verbal and written communication Excellent customer service skills Proficient computer skills and knowledge of Microsoft Office Ability to prioritize and manage multiple tasks Reports To: Department Manager Approved by: Human Resources Solid ability to learn new technologies and possess the technical aptitude required to understand flow of data through systems as well as system interaction Requirements Minimum Job Qualifications: High School Diploma or equivalent One (1) year work related experience in health care administrative, financial, or insurance customer services, claims, billing, call center or management regardless of industry Senior level requires two (2) years of work-related experience and one (1) year of exact job experience Exact job experience is considered any of the above tasks in a Medicare certified HME, Diabetic, Pharmacy, or home medical supplies environment that routinely bills insurance. AdaptHealth is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual's race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.

Acuity Inc. (NYSE: AYI) is a market-leading industrial technology company. We use technology to solve problems in spaces, light and more things to come. Through our two business segments, Acuity Brands Lighting (ABL) and Acuity Intelligent Spaces (AIS), we design, manufacture, and bring to market products and services that make a valuable difference in people's lives. We achieve growth through the development of innovative new products and services, including lighting, lighting controls, building management solutions, and an audio, video and control platform. We focus on customer outcomes and drive growth and productivity to increase market share and deliver superior returns. We look to aggressively deploy capital to grow the business and to enter attractive new verticals. Acuity Inc. is based in Atlanta, Georgia, with operations across North America, Europe and Asia. The Company is powered by approximately 13,000 dedicated and talented associates. Visit us at ****************** Job Summary Create accurate Bill of Materials and assembly drawings for our ERP system that informs the Manufacturing and Assembly teams what to fabricate and how to assemble the product. This is a full-time position, and hours of work and days are varied. Ability to work Monday through Friday (6:30 A.M - 3:30 P.M., 7A.M -4P.M.) Occasional evening and weekend work may be required as job duties demand. Key Tasks & Responsibilities (Essential Functions) Interpret and create drawings for simple to complex product and assembly drawings in order to make accurate BOMs. Creation of BOMs and drawings for individual parts, sub-assemblies and finished products. Modify/Update existing BOMs to meet the needs of new specific requirements. Develop drawings for new custom parts needed in the BOMs. Work collaboratively with Engineering and Design Assist Departments. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Experience (minimum experience required) Proficient knowledge working in Windows environment and software related (Outlook, Office, etc.). Knowledge of engineering Solid works software. Knowledge and understanding of the concept of Bills of Materials and how they are built. Ability to learn new software and processes. Ability to read and interpret drawings and diagrams. Ability or willingness to learn how to analyze parts, assemblies, and production processes. High capacity to work in a focused and methodical manner. High capacity to work under pressure and fulfill tight deliver schedules. Comfortable working on highly focused tasks. Computer program knowledge should include the following, but training is available for the right candidate: MS Office (excel, PowerPoint, Word), SharePoint SolidWorks Adobe Illustrator & Photoshop (preferred but not essential) Education Minimum - High School Diploma with 1-2 years of drafting technician experience. College or Associate Degree manufacturing or drafting technical education preferred. Preferred Experience (i.e., industry experience) Highly proficient in the use of PC and software related to engineering: 3D modeling 2D technical drawing Data base drawing management The candidate must be a fast learner with excellent retention of knowledge and details Physical Requirements Light Work Work Environment This position is within a professional work environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The employee is exposed to a variety of extreme conditions that may be found while walking the production floor. No travel will be required for this position. #LI-EG1 The range for this position is $36,000 to $64,800. Placement within this range may vary, depending on the applicant's experience and geographic location. Acuity offers generous benefits including health care, dental coverage, vision plans, 401K benefits, and commissions/incentive compensation depending on the role. For a list of our benefits, click here. We value diversity and are an equal opportunity employer. All qualified applicants will be considered for employment without regards to race, color, age, gender, sexual orientation, gender identity and expression, ethnicity or national origin, disability, pregnancy, religion, covered veteran status, protected genetic information, or any other characteristic protected by law. Please click here and here for more information. Accommodation for Applicants with Disabilities: As an equal opportunity employer, Acuity Inc. is committed to providing reasonable accommodations in its application process for qualified individuals with disabilities and disabled veterans. If you have difficulty using our online system due to a disability and need an accommodation, you may contact us at **************. Please clearly indicate what type of accommodation you are requesting and for what requisition. Any unsolicited resumes sent to Acuity Inc. from a third party, such as an Agency recruiter, including unsolicited resumes sent to an Acuity Inc. mailing address, fax machine or email address, directly to Acuity Inc. employees, or to Acuity Inc. resume database will be considered Acuity Inc. property. Acuity Inc. will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Acuity Inc. will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor, but does not have the appropriate approvals to be engaged on a search. E-Verify Participation Poster e-verify.gov eeoc.gov

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role: Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance (“QA”) expertise, leadership and training to ensure adherence with applicable regulatory requirements and company policies/procedures. _ Your Contributions (include, but are not limited to): Primary Function Study Team Support: Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles Develop risk mitigation plans and strategies Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management Provide GCP training as needed, including Investigator Meeting training Quality Systems Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training Proactively research, test and implement quality systems, processes and procedures within CQA area Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives QA Department Support Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned Support all on-site regulatory inspection activities May work on other projects within QA not related to GCP Secondary Functions Good Clinical Practice (“GCP”) Audit Management: Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable. Assist in the audit site selection process for study-specific audit plans. Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker Provide proactive audit status and metrics reports to management Other duties as assigned Requirements: BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or related discipline and 6+ years of similar experience noted above Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired. Experience with gene therapy clinical trials is preferred Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to auditees as well as the Company's management Ability to identify and escalate problems and follow-through with the corrective actions Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent computer skills Excellent communication, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $145,600.00-$199,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Quality Assurance Manager Job Description General Purpose The primary responsibility of this position is to oversight GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally. Main Job Tasks and Responsibilities Responsible for QAU administration. Torrey Pines Solutions is Hiring! We have an immediate need for a Quality Manager. Candidate must have Biotech/Pharma industry GxP experience - No exceptions. Principals only no agencies. For immediate consideration, please contact me at rwilliamson@torreypinessolutions or reviewing required documents for GMP compliance. The maintenance of the document management system. Identify training needs and organize training interventions to meet quality standards Perform the internal/external audit and finalize the audit report Evaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicable Cooperate with internal team/external parties to investigate customer complaints and non-conformance issues Analyze data to identify areas for improvement in the quality system Additional duties as required and assigned Must Have B.S. or M.S. in sciences Prior experience as a QA Auditor Auditing experience of GMP quality standards Ability to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPA Nice-to-Have Working experience with CMO/CRO/Outsourcing Testing Lab (OTL) Drug substance/product or pharmaceutical industry-specific experience Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma Auditing experience of GCP quality standards Experience with implementation of corrective/preventive action programs Knowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines) Key Competencies attention to detail communication skills - verbal and written data collection, management and analysis problem analysis and problem solving planning and organizing judgment decision-making teamwork