Quality assurance manager jobs in Burlington, NC - 235 jobs

Working at Freudenberg: We will wow your world! Responsibilities: Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications. Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision. Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration. Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions. Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations Qualifications: Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience 5+ years experience in a quality leadership or management role Proven experience implementing and maintaining an ISO 9001 compliant QMS Experience managing quality control in a manufacturing environment or testing laboratory The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Performance Materials LP (USA)

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. What You Will Achieve In this role, you will: Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues Additional Qualifications/Responsibilities Here Is What You Need (Minimum Requirements) BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience Substantial experience in pharmaceutical manufacturing and quality control Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects Knowledge of regulations related to vendor management programs and other industry quality systems Strong critical thinking skills and a proactive approach Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms Bonus Points If You Have (Preferred Requirements) Experience in Quality Systems in pharmaceutical, medical device, or combination product industry Knowledge or exposure to data science Strong leadership and team management skills Ability to work under pressure and meet tight deadlines Ability to influence and negotiate with stakeholders Experience in conducting internal audits and supporting regulatory inspections Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use Relocation support available Work Location Assignment: On Premise The annual base salary for this position ranges from $99,200.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

We are a fast-paced business with ambitious growth plans; so if you are dedicated, enthusiastic and always seeking ways to improve, you'll enjoy a career with us! Ontic is a leading global aerospace OEM trusted by the world's aviation leaders. Ontic's Creedmoor, NC, site is home to a number of specialist companies within the Ontic Group, including Firstmark, Twin Commander, and Metro Merlin. With over 1,300 employees across four time zones and seven sites, we have more than doubled in size since 2019 and are continuing to grow at pace. Our team is looking for a Quality Assurance Manager to join them. You will report to the Director of Quality and will have an onsite work structure in Creedmoor, North Carolina. To be considered for the Quality Assurance Manager opening, here's what you'll need to bring with you: Bachelor's degree in engineering or related field 10 years of Quality experience in an aerospace manufacturing environment in with a minimum of 5 years in a leadership position Full knowledge of the regulatory environment Ontic operates in i.e., CFR 21, CFR 145, AS9100/AS9110, DFARS, as well as customer and other government requirements As a Quality Assurance Manager, you will: Act as a primary point of contact for all customer and regulatory Quality matters; support product and process verification initiatives and continuous improvement activities. Be change agent to drive quality culture change across the business Become the SME for Quality for the product value streams with a detailed understanding of the manufacturing and quality processes Responsible for the adherence to all customer requirements Build and lead the quality analytical and purchase order review process to ensure contractual compliance Lead and support from a quality perspective all BAU license transfer and licensor/customer engagement activities Maintain and track quality for the purposes of analysis, control, improvement and management reports and maintains a quality system in compliance with applicable standards and regulations Quality representative for AS9100 compliance requirements Implement a quality culture of strong root cause analysis and sustainable corrective actions in parallel while ensuring that a robust Quality Clinic and MRB processes are maintained Verify the sites quality assurance objectives and processes are aligned with corporate goals Provide effective organizational structure with proper training, coaching, and oversight as necessary as well as succession planning to achieve operational best practices Support as needed cross-functional improvement activities across various value streams. Be a focal point for continuous improvement and manage problem solving investigations and reporting (RCCA) Develop systems, methods to measure, and process and product monitoring to ensure compliant product. Provide effective interdepartmental communications with other departments and organizations to provide an atmosphere of cooperation Manage and maintain a group of employees capable of adapting to a dynamic business and manufacturing environment with focuses on continuous improvement, process improvements, effective communication, professionalism and efficiency Other responsibilities as assigned Our Benefits: Comprehensive medical insurance Competitive PTO, holiday pay, and sick leave Company 401K plan with up to 4% matched contribution Annual bonus program (varies by level and discretionary based on company and individual performance) Flexible working arrangements Paid volunteering opportunities Access to mental health champions across our sites Commitment to development Employee referral program #LI-Onsite EOE/Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran Compensation Pay Range $110,000-$140,000/yr based on experience Please click here to review Ontic's California Consumer Privacy Act policy. Ontic Engineering and Manufacturing Inc. is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. This position must meet export control compliance requirements. To meet export control compliance requirements, a “U.S. Person ” as defined by 22. C.F.R. §120.15 is required. “U.S. Person” includes U.S. Citizen, lawful permanent resident, asylee, or refugee.

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities Acts as a key advocate for quality excellence across all levels of the organization Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network Actively participates in cross-functional initiatives to align global quality strategies Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities Performs other duties, as assigned Minimum Requirements: • Bachelor's degree in engineering, life sciences with 13+ years of related experience OR • Master's degree in engineering, life sciences with 11+ years of related experience OR • Ph.D. in engineering, life sciences with 9+ years of related experience • 10+ years of people management, leadership, and team management experience • Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility. • Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. • Experience collaborating and interacting with a global team. • Training and/or familiarity with Quality Risk Management principles Preferred Requirements: • 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering) • Strong track record of driving operational excellence • Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

About the Role North Carolina Rural Hall Remote vs. Office Office/Site only Company Siemens Energy, Inc. Organization Gas Services Business Unit Central Full / Part time Full-time Experience Level Experienced Professional A Snapshot of Your Day The Quality Assurance Manager will lead the team of Quality Engineers, NDE Level III, Metallurgical Lab, Metrology Lab, and Quality Lead responsible for product/process integrity in Winston Technology Center where industrial turbine components such as blades, vanes, and small turbine components through the development and implementation of systems that support internal processes such as the nonconformance system, root cause analysis, 8D corrective actions, audits, trend analysis, integrated management systems - ISO9001 and other plant Quality related activities. How You'll Make an Impact * Define and implement strategies to achieve quality objectives while driving quality improvement projects across the shop floor and other business areas. * Act as a Change Agent within a diverse organization, leading the Quality Assurance Program and Quality Management System (QMS). * Report quality issues, performance metrics, and trends to management and cross-functional teams, ensuring transparency on status and progress. * Analyze strengths and weaknesses of Quality systems, identify improvement areas, and set coordinated targets while facilitating standard process sharing. * Collaborate with cross-functional teams to achieve superior business results and build a motivated team of Quality professionals and technicians. * Support supplier development, conduct new supplier audits, and manage existing supplier renewals, while overseeing the 8D corrective/preventive action database. * Utilize customer field issues, internal Non-Conformance Reports (NCRs), and audit findings to drive 8D activities and track nonconformance costs related to quality issues. What You Bring * Bachelor's degree in Mechanical, Electrical, or Industrial Engineering is preferred, or a technical diploma with 12+ years of relevant experience. * NDE Level III certification in 3 or more methods (e.g., Phased Array UT, PT, MT, ECT, RT, Thermal Infrared NDE) preferred. * 8 or more years of experience in product manufacturing and Quality department roles. * Proven leadership and team management experience with a focus on optimizing performance and development. * Ability to foster a collaborative team environment. * Strong analytical and problem-solving skills. * Excellent communication, presentation, interpersonal, and influencing abilities. * Knowledge of ISO 9001; certification as an experienced auditor preferred. * Proficiency in MS Office applications. * Applicants must be legally authorized for employment in the United States without need for current or future employer-sponsored work authorization. Siemens Energy employees with current visa sponsorship may be eligible for internal transfers. About the Team Gas Services Our Gas Services division offers Low-emission power generation through service and decarbonization. Zero or low emission power generation and all gas turbines under one roof, steam turbines and generators. Decarbonization opportunities through service offerings, modernization, and digitalization of the fleet. Who is Siemens Energy? At Siemens Energy, we are more than just an energy technology company. With ~100,000 dedicated employees in more than 90 countries, we develop the energy systems of the future, ensuring that the growing energy demand of the global community is met reliably and sustainably. The technologies created in our research departments and factories drive the energy transition and provide the base for one sixth of the world's electricity generation. Our global team is committed to making sustainable, reliable, and affordable energy a reality by pushing the boundaries of what is possible. We uphold a 150-year legacy of innovation that encourages our search for people who will support our focus on decarbonization, new technologies, and energy transformation. Find out how you can make a difference at Siemens Energy: ******************************************** Rewards * Career growth and development opportunities * Supportive work culture * Company paid Health and wellness benefits * Paid Time Off and paid holidays * 401K savings plan with company match * Family building benefits * Parental leave Jobs & Careers: ************************************ Equal Employment Opportunity Statement Siemens Energy and Siemens Gamesa Renewable Energy is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. California Privacy Notice California residents have the right to receive additional notices about their personal information. Click here to read more.

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America's Best Startup Employers of 2024,” and honored as one of BioSpace's “2025 Best Places to Work.” Role Overview The Manager, Quality Assurance Validation Contractor plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment. This position provides support and quality assurance guidance to the Technical Operation's department ensuring that the lifecycle of the validation program follows all regulatory requirements. In this role, you will use your knowledge to ensure site validation activities align with Kriya's Validation Policy, Site Validation Master Plan, and applicable Quality Systems. Key Responsibilities Collaborate with cross-functional teams to develop and execute a robust validation strategy for equipment, utilities, and computer software assurance (CSA), that align with regulatory requirements. Work with various departments to define the validation scope, deliverables, and timelines. Review and approve validation documents including SOPs, protocols, specifications, test scripts, acceptance criteria, and reports. Ensure implementation, operation, and validation of GXP computerized systems follow GAMP 5 guidelines. Participate in risk assessments related to GXP equipment, utilities, and computerized systems. Identify and address potential risks to data integrity, security, and safety. Provide quality support for change control processes and activities that occur for any modifications to existing or new systems, equipment, instruments, or utilities to ensure validation requirements are assessed and fulfilled. Review/approve validation exception records and investigations. Opportunity to participate in CSV vendor audits. Support biennial reviews of validated systems as required. Provide various quality support in other areas of Quality that include batch record review, data review, material release, vendor and regulatory audits, SOP review, and other document reviews, as needed. Experience & Skills 5+ years of industry experience. Minimum - Bachelor's or Masters's degree preferably in an Engineering, Science, Technical, or related fields. Relevant certifications such as CQA are preferred. Minimum of three (3) years of experience in Quality Assurance and Validation within the biotechnology workforce. Thorough knowledge of applicable regulations and standards related to validation activities Experience working in a cGMP environment Detailed knowledge of GAMP 5 applications and CSA approach. Proficiency in Microsoft Suite Ability to manage daily work activities of this role with minimal supervision Strong orientation for quality and cGMPs Strong collaborative skills Highly self-motivated and detail oriented Demonstrated level of respect for individuals High level of integrity and personal responsibility Work Environment Primarily desk-based, generally in an office or home office setting. May involve extended periods of sitting and computer use. Some lifting of equipment or materials may be required. Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees All job requirements in the provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

The Associate Quality Assurance Manager supports The Upper Deck Company's business units by assisting in the oversight of the Shipping and Quality Assurance departments. This position is ideal for a motivated, detail-oriented professional with strong organizational skills, leadership potential, and experience using project management and data analytics tools to improve workflow and performance. Working closely with the Quality Assurance Manager, this role helps ensure that every product meets Upper Deck's high standards for quality and accuracy while supporting the continued growth and development of team members. ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned * Support the daily operations of the Shipping and QA departments, maintaining focus on accuracy, efficiency, and on-time project completion. * Supervise QA and Shipping team members, providing coaching, feedback, and assistance with problem-solving. * Use project management software (e.g., Asana, Monday, Smartsheet) to organize priorities, track progress, and communicate updates. * Generate and interpret data reports and quality metrics to identify areas for improvement, reduce errors, and support decision-making. * Collaborate with Project Coordinators, Talent Relations, and Brand Management teams to resolve discrepancies and maintain alignment across departments Support continuous improvement initiatives and standard operating procedure (SOP) development. * Take initiative in identifying process improvements and helping implement new tools or methods that enhance quality and efficiency. INTERACTION This position will interact closely with the Quality Assurance Manager, Talent Relations, Project Managers, Project Coordinators. SUPERVISORY RESPONSIBILITIES Supervisory responsibilities for Boxing, QA, Shipping Clerks. EDUCATION/YEARS EXPERIENCE * Bachelor's degree in business management, Operations, or a related field, or equivalent work experience. * 3-5 years of experience in project coordination, operations, or quality assurance. * Demonstrated success in managing teams and improving performance through data analytics and technology-based solutions. * Experience using project management software and working with data reporting tools. REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. KNOWLEDGE, SKILLS AND ABILITIES * Proficient in project management software (e.g., Asana, Monday, Smartsheet) and data visualization tools (e.g., Excel, Power BI, Tableau). * Strong analytical, problem-solving, and troubleshooting abilities with a data-focused mindset. * Excellent communication and interpersonal skills for cross-departmental collaboration. * Highly organized with the ability to manage multiple high-priority initiatives simultaneously. * Self-motivated leader with a hands-on approach and professional demeanor. * Strong commitment to quality, accuracy, and continuous improvement.

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment * Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements * Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards * Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation * Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary * Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements * Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle * Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed * Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards * Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness * Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities * Acts as a key advocate for quality excellence across all levels of the organization * Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility * Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. * Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network * Actively participates in cross-functional initiatives to align global quality strategies * Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations * Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments * Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines * Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management * Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success * Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies * Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities * Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in engineering, life sciences with 13+ years of related experience OR• Master's degree in engineering, life sciences with 11+ years of related experience OR• Ph.D. in engineering, life sciences with 9+ years of related experience• 10+ years of people management, leadership, and team management experience• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.• Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.• Experience collaborating and interacting with a global team. * Training and/or familiarity with Quality Risk Management principles Preferred Requirements: * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering)• Strong track record of driving operational excellence• Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location Information: High Point, NC Click here for site video: High Point Softgels Essential Duties and Responsibilities Ensures that the QC laboratory is well-equipped with the necessary personnel to conduct timely testing of non-commercial and pre-commercial samples, encompassing both process and cleaning validations. Provide mentorship and technical support to staff in troubleshooting instrumentation, root cause analysis, and implementing Corrective/Preventative Actions (CAPAs). Collaborate with internal and external customers to support site and company initiatives. Uphold and implement safety regulations and company policies. Conduct regular 1-on-1 mentoring sessions and annual performance evaluations for team members. Represent Quality Control during audits and regulatory inspections. Qualifications BS degree with 8 years of laboratory experience preferably within a cGMP, pharmaceutical laboratory environment, including 2-3 years of supervisory experience. Meet applicable DEA security clearance requirements. Skilled in the interpretation of guidelines and employing rational or scientific reasoning. Proficiency in operating basic and complex laboratory equipment and software such as Empower, Chromeleon, MS Word, and Excel.

- The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients Essential Functions Author or act as author for lab investigations, deviations, protocols and specifications for raw materials. Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines. Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks. Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements Interact with third party laboratories for microbial and analytical testing of raw materials Generate and/or review shipping paperwork for third part testing and prepare samples for shipment. Create purchase requisitions for lab supplies and third-party testing Perform weekly laboratory audit inspections Perform sampling of raw materials as needed Review third party laboratory investigations and protocols. Provide technical support to the laboratory for method and instrument troubleshooting as needed. Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques. May perform testing of raw materials, packaging components, and other samples as needed. Other duties as assigned Supervisory responsibilities : Direct Reports: Yes Indirect Reports: None Key Relationships: Manufacturing Operations Quality Assurance Analytical R&D Program Management Travel requirements : None Education and Experience Minimum BA or BS in a scientific discipline required Minimum of 5 years of prior supervisory experience. Minimum 5-7 years in an Analytical development or Quality Control setting for Pharmaceutical Products or Raw Materials preferred Experience establishing and maintaining relationships with key decision makers Knowledge, Skills, and Abilities Knowledge of cGMPs Good communication, organization and computer skills are required. Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired. Ability and willingness to work additional hours as required by business need At least 5 years' experience in a CRO environment Experience with USP, EP and JP monographs. Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size. Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders Excellent verbal and written communication skills Ability to work with minimal supervision Experience in Data Review of Analytical data per GDP guidelines. Proven ability to review and evaluate the compliance and completeness of analytical data. Able to multi-task productively, applying time management processes and procedures effectively. Works toward common goals by supporting, encouraging, and sharing information with colleagues. Strong analytical skills and ability to understand business and financial implications of contracts Self-directed Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. Requires frequent sitting and walking Requires carrying under 20 LBS, occasionally 20 - 60 LBS Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS Requires occasional bending, twisting, reaching, & gripping Requires constant seeing & hearing Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Regulatory & Manual Compliance Ensure all aircraft and article maintenance performed under the Repair Station Certificate conforms to FAR Part 145 Section 145.201 and procedures defined in the Repair Station Manual. Provide guidance to employees regarding the application and interpretation of Federal Aviation Regulations and manual requirements based on job classifications. Evaluate recommendations for changes to Repair Station and QC manuals; coordinate revisions with the Chief Inspector. Department Leadership & Staffing Oversee daily operations of the Quality Control Department, including staffing and competency evaluation of QC Inspectors. Ensure QC personnel maintain proficiency and capabilities required for airworthiness releases. Support and monitor maintenance training programs to ensure they meet organizational and customer needs. Inspection & Airworthiness Oversight Ensure no unserviceable, defective, or un-airworthy parts are installed on aircraft or components released by the Repair Station. Coordinate with Project Managers and customers to support inspection assignments, Required Inspection Items (RII), and Return-to-Service (RTS) requirements. Review vendor- and manufacturer-issued technical documentation affecting quality or airworthiness. Customer & Vendor Interface Serve as liaison with: FAR Part 121 air carriers (as applicable) Customer and vendor Records Departments Regulatory partners, suppliers, and quality representatives Leadership Duties & Delegation Assume responsibilities of Chief Inspector/Accountable Manager during their absence. May delegate departmental tasks to qualified personnel; however, maintains full accountability for QC operations and compliance. Safety & Operational Standards Ensure appropriate equipment, materials, and personnel resources are maintained to support compliance and production needs. Promote and maintain a safe working environment for all QC staff.

Job Description Regulatory & Manual Compliance Ensure all aircraft and article maintenance performed under the Repair Station Certificate conforms to FAR Part 145 Section 145.201 and procedures defined in the Repair Station Manual. Provide guidance to employees regarding the application and interpretation of Federal Aviation Regulations and manual requirements based on job classifications. Evaluate recommendations for changes to Repair Station and QC manuals; coordinate revisions with the Chief Inspector. Department Leadership & Staffing Oversee daily operations of the Quality Control Department, including staffing and competency evaluation of QC Inspectors. Ensure QC personnel maintain proficiency and capabilities required for airworthiness releases. Support and monitor maintenance training programs to ensure they meet organizational and customer needs. Inspection & Airworthiness Oversight Ensure no unserviceable, defective, or un-airworthy parts are installed on aircraft or components released by the Repair Station. Coordinate with Project Managers and customers to support inspection assignments, Required Inspection Items (RII), and Return-to-Service (RTS) requirements. Review vendor- and manufacturer-issued technical documentation affecting quality or airworthiness. Customer & Vendor Interface Serve as liaison with: FAR Part 121 air carriers (as applicable) Customer and vendor Records Departments Regulatory partners, suppliers, and quality representatives Leadership Duties & Delegation Assume responsibilities of Chief Inspector/Accountable Manager during their absence. May delegate departmental tasks to qualified personnel; however, maintains full accountability for QC operations and compliance. Safety & Operational Standards Ensure appropriate equipment, materials, and personnel resources are maintained to support compliance and production needs. Promote and maintain a safe working environment for all QC staff.

Our Company ResCare Community Living Work in conjunction with diverse clinical teams and utilize community resources to meet the needs of individuals receiving care management services. Provide services in accordance with care management service requirements set by the state and company. Responsible for developing and monitoring Tailored Care Management care plans and Individual Support Plans (ISPs) built from comprehensive assessments to an assigned caseload. Responsibilities Develops positive relationships among and between members, family/guardians, Extenders, clinical and care team members and other community stakeholders to create an environment of compassion and professionalism, driving toward positive health and quality of life outcomes. Responds proactively to alerts from Extenders concerning unmet health-related needs and identified barriers and gaps to reduce adverse health and quality of life indicators. Develops positive relationships with all funding sources that exhibits the willingness to obtain common objectives related to care management. Engages the member/family/guardian to establish rapport and provide required and as needed contact, ensuring service provision is up to date and follow through is completed. In conjunction with the member, selects members for the care team (adjusting as needed). Conducts the Comprehensive Health Assessment on the member, with stakeholder input, to obtain baseline information needed to formulate a care plan. Coordinates, schedules, sets the agenda for and assists the member in chairing care team meetings (times, dates, locations, etc.) and informs all team members. Develops, implements, reassesses, oversees the implementation of and evaluates the Care Plan/ISP for the member to ensure that the members health needs are addressed in a comprehensive, holistic, and preventive manner, with quality as a goal. Manages care transitions and transition plans. Ensures medication monitoring and reconciliation occur. Monitors/implements/supervises delivery of service plans and personal futures plan and training of staff. Documents all information gathered/received electronically in a timely manner. Provides documentation of billable events that align with minimum contact expectations to the Care Management Supervisor. Maintains an accurate, up-to-date electronic information data stream on all interactions, encounters, activities, care team meetings, and communications with the member/family/guardian. Promotes and coordinates comprehensive care among medical, pharmaceutical, psychosocial, social, mental, physical, home health, ancillary providers, and other community agencies, supporting individuals with referrals as needed. Connects members with medical, mental, developmental, psychosocial, housing, transportation, home health, and community support services/systems to achieve a comprehensive, holistic, preventive approach. Empowers the member/family/guardian and other team members with knowledge that aids in implementing the care plan, treatment plan, medication regimen, and appointment keeping. Identifies barriers, gaps, and unmet health-related needs are addresses them proactively, expanding relationships and linkages to aid in meeting member's needs. Supervises up to two FTEs of care management extenders. Provides services that meet national, state, and local healthcare standards at the highest level. Reports issues of concern, general departmental activities and staffing needs to the Care Management Supervisor. Completes all required training and participates in educational sessions to improve overall skills. Attends industry meetings, training, and functions to promote positive relationships with stakeholders. Participates in quality improvement and measurement activities to achieve identified targets and outcomes. Completes other duties as assigned. Qualifications Qualifications: Years of experience as specified below. Two years of experience as a Care Manager, Case Manager, or Care Coordinator preferred. Ability to perform work with a high degree of quality and autonomy. Must meet all agency requirements for pre-employment and those required by the state of NC. Education: A license, provisional license, certificate, registration, or permit issued by the governing board regulating a human service profession, except a registered nurse who is licensed to practice in the State of North Carolina by the North Carolina Board of Nursing who also has four years of full-time accumulated experience with the IDD population; or A Master's degree in a human service field and one year of full-time, post-graduate degree accumulated experience with the IDD population; or A bachelor's degree in a human service field and two years of full-time, post-bachelor's degree accumulated experience with the IDD population; or A bachelor's degree in a field other than human services and four years of full-time, post-bachelor's degree accumulated experience with the IDD population; and For care managers serving members with LTSS needs: two years of prior LTSS and/or HCBS coordination, care delivery monitoring, and care management experience, in addition to the requirements cited above. (This experience may be concurrent with the two years of experience working directly with individuals with I/DD, or a TBI, above.) About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn. Salary Range USD $21.64 - $26.44 / Hour

Set the Standard for Excellence - Quality Control Manager, Forensics Precision matters. Credibility matters. The City of Greensboro Police Department is seeking a Quality Control Manager for its Forensic Services Division-a leadership role for a professional who understands that behind every investigation is a system that must be accurate, defensible, and trusted. This position is central to protecting the integrity of forensic work that supports public safety and justice. Compensation and Benefits: Estimated Hiring Salary Range: $82,911.00 - $89,676.00 Full Salary Range: $68,154.00 - $121,959.00 Annually Benefits: The City of Greensboro offers an outstanding benefits package that supports your well-being. Learn more Here Work Schedule: Monday-Friday 8:00 am - 5:00 pm About the Department: The Forensic Services Division provides specialized inspections and services in friction ridge analysis, firearms and toolmarks, crime scene investigations, forensic imaging, and property and evidence management. The Division supports law enforcement, the courts, and the community by delivering scientifically sound, objective, and defensible forensic services. Quality, consistency, and accountability are foundational to everything the Division does. Why You'll Love Working With Us: * Purpose-driven leadership: Your work directly supports justice, public trust, and investigative integrity * Professional respect: This role is empowered to make decisions, set standards, and lead improvements * Inclusive environment: We value diverse perspectives and collaborative problem-solving * Continuous improvement mindset: Training, innovation, and excellence are not optional-they're expected About the Role: The Quality Control Manager coordinates and administers inspection service quality across all forensic disciplines while ensuring compliance with ISO/IEC 17020 standards, applicable laws, and departmental policies. Key responsibilities include: * Developing, implementing, and maintaining the Division's Quality Assurance System * Leading efforts to expand accreditation to include crime scene investigations * Conducting audits and monitoring forensic practices for compliance and consistency * Investigating nonconformities and managing corrective actions and root-cause analyses * Providing on-site procedural oversight during inspections and field operations * Managing proficiency testing programs, including internal test development * Coordinating court testimony reviews and customer feedback programs * Drafting and updating quality-related policies, procedures, and training materials * Organizing and delivering training for staff and community partners * Overseeing equipment maintenance, calibration, vendor selection, and purchasing activities This role requires confidence, attention to detail, and the ability to balance technical expertise with leadership. Potential Career Path: This position offers a strong pathway into: * Senior Forensic or Accreditation Leadership * Department-wide Quality, Compliance, or Risk Management roles * Executive leadership within forensic or public safety operations Take the Next Step: If you are driven by accuracy, accountability, and continuous improvement-and want your work to directly support public safety-we encourage you to apply. Apply today and help the City of Greensboro Police Department uphold the highest standards in forensic services. Minimum Qualifications: * Bachelor's Degree or higher with 7+ years of full-time experience in forensic inspections or testing, including at least five (5) years as an administrative/accreditation specialist, operator, supervisor, or manager performing quality assurance duties in accordance with ISO/IEC 17020 or 17025 standards. * "Or" an equivalency of an Associate's Degree with 14+ years of full-time experience in a forensic inspection or testing, including at least five (5) years as an administrative/accreditation specialist, operator, supervisor, or manager performing quality assurance duties in accordance with ISO/IEC 17020 or 17025 standards. * Must obtain the following: within 6 months of hire date: * National Crime Information Center General Inquiries (Model 1) * First Responder/CPR, and Traffic Control certifications. * Must obtain the following certifications: within 1 year of hire date: * Department of Health and Human Services Chemical Analyst Certification; * Must obtain within 1 year of testing eligibility: * Certification through the International Association of Identification in a Forensic Discipline Specific to assignment (Crime Scene, Digital Imaging etc.). * Successful completion within six (6) months of eligibility is required: * Assessor or Internal Auditor training * Demonstrated experience applying ISO/IEC 17020 or 17025 quality assurance practices (e.g., Audits, proficiency testing, and corrective actions; Calibration and maintenance of instruments/equipment; Policy and form development; Document control and record management) * Valid Driver's License. Preferred Qualifications: * 3 years as a Quality Assurance Manager * Experience as a forensic unit/squad supervisor * Experience training or instructing forensic practitioners * Experience conducting crime scene investigations/evidence inspections, friction-ridge examinations, firearm/tool mark examinations or forensic/digital imaging processes. * Experience with individual characteristic database systems (e.g., AFIS - Automated Fingerprint Identification System or IBIS - Integrated Ballistic Information System) * Experience within a CALEA-accredited agency * Training and/or experience as an ISO/IEC 17020 or 17025 assessor or quality auditor * Must obtain additional specialized certifications as needed.*

WHAT MAKES US EPIC? At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating. Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development. QUALITY ASSURANCE What We Do The Quality Assurance team owns the testing process, risk management, and quality evaluation of all products and functions across Epic. Our team works closely with developers and production to ensure the best possible user experience for our community and customers. What You'll Do We're looking for an experienced QA Manager for our Online team! In this role, you will be a leader in developing a quality strategy. You will be guiding quality for our Distribution team, partnering with other discipline leads, and innovating and improving our quality processes. If you are passionate about leading and mentoring experienced QA professionals in an exciting, fast-paced environment, we'd love to talk to you! In this role, you will Lead, manage, and mentor a diverse QA organization within the Distro team, including functional testers and external partners, QA analysts, engineers, and SDETs. Support growth across all QA disciplines while effectively managing and mentoring senior QA SMEs with deep domain and technical expertise. Own the Distro Quality Strategy and quality signals, accounting for staffing constraints, backend services, and distributable applications. Ensure QA engagement throughout the full development and release lifecycle while using KPIs, metrics, and qualitative signals to assess product quality, testing effectiveness, and release risk, and to drive continuous improvement. Drive prioritization and execution in a dynamic operating model, where QA supports testing, release validation, and live support. Balance competing priorities, unplanned work, and external requests to prevent QA from becoming a bottleneck while maintaining appropriate quality standards in a low-risk-tolerance environment Guide release readiness and provide cross-pod oversight, collaborating closely with engineering, product, and stakeholder teams to determine test scope, release timing, and acceptable risk. Collaborate with QA leadership across Epic to identify cross-product risks, dependencies, and mitigation strategies. Communicate clearly and effectively across teams and stakeholders, explaining priority shifts, risk trade-offs, and release decisions to QA teams, partner teams, and leadership. Remain technically capable and hands-on when required, stepping in to support testing or releases during coverage gaps, and maintaining sufficient technical depth to engage credibly with QA engineers and developers What we're looking for Proven senior experience leading QA teams with mixed skill sets and seniority, including technical and non-technical contributors, external partners, and senior QA SMEs. Demonstrated ability to mentor experienced ICs while providing clear direction and accountability Proven strong understanding of testing and releasing both backend services and distributable applications, including APIs, services, and client-facing software, with an appreciation for the differing risks and validation strategies involved Exceptional prioritization and operational judgment, particularly in understaffed, fast-paced environments with multiple stakeholders and low tolerance for risk Experience supporting release management activities, making informed decisions around test scope, release readiness, and risk acceptance, and setting clear expectations with internal and cross-team stakeholders Solid technical foundation in modern QA practices, including test automation, CI/CD integration, testability, and quality metrics, with the ability to contribute directly when needed Strong communication skills, able to clearly explain priority shifts, risks, and trade-offs to QA teams, partner teams, and leadership Expert-level use of quality metrics and KPIs to guide prioritization, forecast risk, and drive continuous improvement across products, processes, and teams EPIC JOB + EPIC BENEFITS = EPIC LIFE Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical. ABOUT US Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent. Like what you hear? Come be a part of something Epic! Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here. Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.

Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines. Responsibilities Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions. Qualifications/Skills Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills. Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i. e. , beyond just USP compendial testing). Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals. Position also requires visual acuity, talking, writing, and typing. BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions.

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager, Quality Control Microbiology What you will do Let's do this. Let's change the world. In this vital role, you will manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring, clean utilities' monitoring, and routine microbiological testing to support drug substance manufacturing. The Manager, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing, and production in-process and final drug substance testing. Manage the training program for sampling and testing team. Assist with planning, scheduling, and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes. Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling, coordinating activities with manufacturing operations, reviewing and interpreting data, and writing trend reports. Act as Subject Matter Expert for method families and testing platforms used in the microbiology department. Work cross-functionally with Manufacturing, Analytical Sciences, Facilities & Engineering, and Quality teams to align processes with business needs. Author, revise, and review documents and reports including but not limited to: SOPs, safety assessments, trend reports, qualification/validation summary reports, microorganism assessments, and technical reports. Represent the microbiology department during agency inspections and internal audits. Work closely with the global Quality Control organization to drive standardization of testing processes and procedures. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Lead process improvement projects that may be local or global in scope. Support routine activities over the weekends and public holidays as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager Quality Control Microbiology we seek is a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate's degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor's degree and 5 years of Quality or Aseptic Manufacturing experience OR Master's degree and 3 years of Quality or Aseptic Manufacturing experience OR Doctorate degree And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Strong leadership skills, with the ability to manage multiple direct reports. Degree in Microbiology, Biology, Biochemistry, or related scientific field. Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data. Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC. Experience with equipment validation. Solid understanding of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 122,421.00 USD - 142,851.00 USD

Agency Safety Division 70000075 Dept of Public Safety Job Classification Title Youth Counselor (S) Number 60096303 Grade NC08 About Us The Department of Public Safety's mission is to safeguard and preserve the lives and property of the people of North Carolina through preparation, prevention, and protection with integrity and honor. Our agency houses many public safety divisions, including Emergency Management, Juvenile Justice and Delinquency Prevention, Alcohol Law Enforcement, Samarcand Training Academy, and the North Carolina National Guard. Join us along with our more than 3,000 employees and 12,000 National Guard members in providing exceptional public safety services to the citizens of North Carolina. Description of Work We are looking for candidates who have a passion for helping court-involved youth. We are Working Together to Strengthen North Carolina's Youth and Families! The Division of Juvenile Justice and Delinquency Prevention is committed to the reduction and prevention of juvenile delinquency by effectively intervening, educating and treating youth in order to strengthen families and increase public safety. If you have a passion for making a difference in the lives of North Carolina's youth, we welcome you to be part of the team. The State of North Carolina provides work/life balance, a team-oriented culture, opportunities for advancement, and interesting work. If you are looking to serve others, this is the place for you Positions will report directly to the Facility assigned Regional Manager Work Schedule will be primarily 10am-7pm. With 1 weekday per week being 1pm-10pm. Expected to work 1 Saturday and 1 Sunday throughout the month. Job Duties for this position require driving a state vehicle. A valid driver's license must be obtained by hie date. Job Duties: -Facility point of contact for peer review, policy compliance, and quality assurance. -Provides oversight on ERC late scans reports; propose late scan improvement ideas to management. -Reviews case notes and records in NC-JOIN for accuracy. Ensures quality of daily case notes in NC-JOIN. Makes daily visits to juveniles on room confinement, completes confinement/behavior documentation, and makes recommendations to management for extension or removal from special management status. -Community support and facility programming by connecting to volunteers, motivational speakers, community partners, etc. plans, supervises, and supports organized recreation, sports events, and weekend/holiday programming. Assists with major events at the facility (graduation, fun days, college/job fairs, spontaneous incentives for juveniles, staff appreciation/service awards, special programs, etc) -Assists Facility Field Specialist positions by scheduling and training setup, identify equipment needs, serve as an ILT, and reviews TROI reports. -Assists the facility in preparation for audits and site visits with outside agencies; assists in all drills, ensures that follow-up is made with each juvenile that raised issues after the site visit debriefings. -Assists with camera footage review to ensure policy compliance and best practices; makes recommendations for improvements -Assists with juvenile intakes, court appointments, adult stay juvenile court dates, attorney contacts, medical appointments, etc., serves as secondary point of contact for HB834 designated juveniles; ensures that juvenile photographs, demographics, housing unit assignments, and juvenile location information in NC-JOIN are updated regularly. -Coordinates space and schedules employees and/or juveniles for interviews for investigations -Assists with annual fiscal inventory; maintain supplies; recommend supply reorder; manages facility canteen program; p-card purchases. -Assists with scheduling and supervising special visits at the facility (attorney, family, therapy, JCCs, etc.) -Assists with completing approved juvenile phone calls to family, JCCs, and attorneys; ensures documentation is completed on the phone log. Assists with making parental notifications regarding intakes, incidents, and room confinement placement. -Assists with special transports for juveniles that are high-risk; assists with transportation and supervision at off-campus outings or special recreational events. -Ensures that juvenile grievances and special conditions appeal forms are collected, tracked, responded to, and filed in a timely manner. Coordinates Step 2 and Step 3 grievance responses when the Step 1 facility response is appealed by the juvenile. Knowledge Skills and Abilities/Management Preferences Salary Range: $37,782-$66,120 Grade: NC08 DPS uses the Merit-Based Recruitment and Selection Plan to fill positions subject to the State Human Resources Act with the most qualified individuals. The Minimum Education and Experience (E&E) are REQUIRED to qualify for this position. All work history and education (including accurate dates of employment/attendance) must be documented on the application. Supplemental Questions are also a required part of the application: answers must reference education or work experience listed on the application. A complete, all-inclusive application maximizes an applicant's potential to qualify for the position, as well as the highest possible salary. Salary will be based on relevant qualifications, internal equity, and budgetary considerations pertinent to the advertised position. State Government Application Resources | NC Office of Human Resources Management Preference: These skills are not required but managers may choose to interview/select applicants who demonstrate Management Preferences. Demonstrated knowledge of adolescent development Demonstrated experience with counseling skills Demonstrated experience with crisis intervention techniques Demonstrated experience working with minority groups Demonstrated experience working with a multidisciplinary service team Please note: You must be physically capable of applying the proper methods and procedures to physically restrain juveniles and defend self after being properly training by the department. The physical demands for this position will be discussed during the interview. This job classification also qualifies for the employee Referral Bonus program. If you were referred to this job posting by a current DPS employee, and you are hired, that employee could qualify for a referral bonus. NEW STEP PAY PLAN! Youth Counselor's enjoy annual salary increases with a step pay plan! Your initial salary is based on your total months of related education and experience above the minimum requirements (Bachelor's degree and 24 months of related experience or equivalent combination of education and experience (6 years)).Please list all work experience in order for you to receive maximum credit. This will help determine the correct salary and step for potential candidates. Candidates will only receive credit for experience documented on the state application. Once hired, your pay will continue to increase as you gain more related experience up to step 6 and you may also qualify for other promotional opportunities. There are many opportunities for promotional advancement within Juvenile Justice! Step 0- $41,558 Step 1- $44,468 Step 2- $47,137 Step 3- $49,494 Step 4- $51,473 Step 5- $53,017 Step 6- $54,078 Work Schedule: This is a full-time position. These positions are required to work shift work and will vary depending on the need of the facilities. Must be able to work weekends, holidays and evenings. Benefits: This is a full-time position (40 hours per week) with State Benefits, including paid vacation, paid sick leave, paid holidays, retirement, and health insurance. To view an example of total compensation, please click here NC OSHR: Total Compensation Calculator Supplemental and Contact Information The North Carolina Department of Public Safety (DPS) is an Equal Opportunity Employer who embraces an Employment First philosophy which consists of complying with all federal laws, state laws and Executive Orders. Consistent with the Americans with Disabilities Act (ADA), we are committed to full inclusion of qualified applicants and will review requests for reasonable accommodation to perform essential job functions during the hiring process or while on the job. Public Service Loan Forgiveness Program For applicants with student loans, becoming a state employee may include eligibility for the Public Service Loan Forgiveness Program. Visit ****************** to learn more. Transcripts Degrees and transcripts must be received from appropriately accredited college or university. Applicants who earned college credit hours but did not complete a degree program, must attach an unofficial transcript to receive credit for education. International degrees and transcripts must be evaluated for accreditation by a recognized evaluation service by the closing date of this posting. Failure to provide documentation may result in ineligibility. The National Association of Credential Evaluation Services (NACES) has several options to provide credential verification :****************************** Military Experience Applicants seeking Veteran's Preference must attach a DD-214 Form (Certificate of Release or Discharge from Active Duty that includes Character of Discharge - Member 4 or Service 2 form) to the application. Applicants seeking National Guard Preference: A current member of the North Carolina National Guard in good standing must attach a NGB 23A (RPAS). A former member of the North Carolina National Guard who served for at least 6 years and were discharged under honorable conditions, must attach either a DD256 or NGB 22. The NC Dept. of Public Safety must adhere to the US Dept. of Justice Final Rule on the "National Standards to Prevent, Detect, and Respond to Prison Rape. "PREA Hiring and Promotion Prohibitions. Selected applicants for positions which are subject to PREA will undergo a PREA-specific background check. Our agency supports second-chance employment for individuals who were previously incarcerated, or justice involved, and we invite all potential applicants to apply for positions for which they may be qualified. Due to the nature of work performed in our agency, prior convictions and/or charges may prohibit employment for positions which are subject to PREA or other position-specific background checks. If applying for a Juvenile Justice & Delinquency Prevention position certified through the NC Dept. of Justice - Criminal Justice Standards Division, please click this link for specific certification requirements: Juvenile Justice Officer & Juvenile Court Counselor Certification. Per NC General Statute 143B-1209.54, applicants hired into a position certified as a criminal justice officer or justice officer are required to electronically submit fingerprints to the NC State Bureau of Investigation for a state and national criminal history record check and enrollment in the FBI's Next Generation Identification System: Criminal Justice Record of Arrest and Prosecution Background Service (“RAP Back”). This is in addition to submitting fingerprints during the application process. Due to the volume of applications received, we are unable to provide information regarding the status of your application. If you are selected for an interview, you will be contacted by the hiring manager. If you are no longer under consideration, you will receive an email notification. #JJ Minimum Education and Experience Some state job postings say you can qualify by an “equivalent combination of education and experience.” If that language appears below, then you may qualify through EITHER years of education OR years of directly related experience, OR a combination of both. See the Education and Experience Equivalency Guide for details. Some state job postings say you can qualify by an “equivalent combination of education and experience.” If that language appears below, then you may qualify through EITHER years of education OR years of directly related experience, OR a combination of both. See the Education and Experience Equivalency Guide for details. Bachelor's degree from an appropriately accredited institution and two years of experience working with the juvenile/family client population and/or related human services experience; or an equivalent combination of education and experience. Necessary Special Qualifications Applicants for positions designated as Juvenile Justice Officers are subject to and must meet the hiring and training standards established by the North Carolina Criminal Justice Education and Training Standards Commission, as defined in Title 12, Chapter 9 of the NC Administrative Code, by the statutory authority of GS 17C. Selected applicant must attend and successfully complete and pass the Juvenile Justice Officer Basic Training certification program. The certification requires three weeks to complete and is comprised of classroom and physically demanding training. This training is carried out at regional training centers and requires consecutive overnight stays. In addition, the selected candidate must: ·Have or be able to obtain required documentation for certification as a Juvenile Justice Officer (i.e. a diploma). ·Pass a Criminal Background check ·Pass a Drug Screening test ·Pass a Psychological test ·Pass a Sexual Risk Screening test ·Pass a Physical (to include Vision and Hearing) ·Be a US citizen ·Be at least 20 years of age ·Have a valid driver's license Click here to learn more about the requirements for Juvenile Justice Officer & Juvenile Court Counselor Certification. EEO Statement The State of North Carolina is an Equal Employment Opportunity Employer and dedicated to providing employees with a work environment free from all forms of unlawful employment discrimination, harassment, or retaliation. The state provides reasonable accommodation to employees and applicants with disabilities; known limitations related to pregnancy, childbirth, or related medical conditions; and for religious beliefs, observances, and practices. Recruiter: Kassia Elizabeth White Recruiter Email: **********************

Job Description - The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients Essential Functions Author or act as author for lab investigations, deviations, protocols and specifications for raw materials. Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines. Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks. Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements Interact with third party laboratories for microbial and analytical testing of raw materials Generate and/or review shipping paperwork for third part testing and prepare samples for shipment. Create purchase requisitions for lab supplies and third-party testing Perform weekly laboratory audit inspections Perform sampling of raw materials as needed Review third party laboratory investigations and protocols. Provide technical support to the laboratory for method and instrument troubleshooting as needed. Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques. May perform testing of raw materials, packaging components, and other samples as needed. Other duties as assigned Supervisory responsibilities : Direct Reports: Yes Indirect Reports: None Key Relationships: Manufacturing Operations Quality Assurance Analytical R&D Program Management Travel requirements : None Education and Experience Minimum BA or BS in a scientific discipline required Minimum of 5 years of prior supervisory experience. Minimum 5-7 years in an Analytical development or Quality Control setting for Pharmaceutical Products or Raw Materials preferred Experience establishing and maintaining relationships with key decision makers Knowledge, Skills, and Abilities Knowledge of cGMPs Good communication, organization and computer skills are required. Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired. Ability and willingness to work additional hours as required by business need At least 5 years' experience in a CRO environment Experience with USP, EP and JP monographs. Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size. Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders Excellent verbal and written communication skills Ability to work with minimal supervision Experience in Data Review of Analytical data per GDP guidelines. Proven ability to review and evaluate the compliance and completeness of analytical data. Able to multi-task productively, applying time management processes and procedures effectively. Works toward common goals by supporting, encouraging, and sharing information with colleagues. Strong analytical skills and ability to understand business and financial implications of contracts Self-directed Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. Requires frequent sitting and walking Requires carrying under 20 LBS, occasionally 20 - 60 LBS Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS Requires occasional bending, twisting, reaching, & gripping Requires constant seeing & hearing Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked. Powered by JazzHR PSMq2DXBY7