Quality manager jobs in Bensalem, PA

Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443

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

Duration: 6 Months Contract We are seeking a Data Exchange Quality Readiness Lead to drive enterprise-level quality governance, data integrity, and release readiness across complex data exchange platforms. This role is responsible for aligning programs, validating end-to-end data flows, ensuring high-quality releases, and enabling operational readiness through governance, testing leadership, and data lineage insights. The ideal candidate brings deep expertise in quality strategy, data systems, cross-functional collaboration, and analytical problem solving. Key Responsibilities Program Alignment & Quality Governance Establish quality governance practices aligned with strategic initiatives and ART delivery models. Partner with ART teams to connect Epics, Product Increments, and scope items. Ensure traceability between acceptance criteria and test plans to guarantee full coverage. Document and enforce Definition of Done across teams. Provide oversight for strategic initiatives including GDE, Workday Wellness, EE Navigator, and OBF integrations (CMC, Event Hub, ADP APIs). Testing Strategy & Execution Define testing strategy across DevQA, Production Simulation, and Production environments. Establish best practices for end-to-end system validation. Ensure release readiness by enforcing quality gates and exit criteria. Champion a quality-first and defect-prevention culture. Data Quality & Lineage Perform hands-on data analysis of inbound source files (Workday, EE Navigator, ADP). Trace processing through Group Data Exchange (GDE) and Group Data Hub (GDH). Validate outbound data flows through routers, APIs, and file processors. Maintain complete data lineage documentation for transparency and auditing. Known Issues & Release Transparency Maintain and publish Known Issues Logs for each release. Track accepted defects and known data differences across GDE, ENE, LADE, and Fineos. Ensure stakeholders have clear visibility into risks before production releases. Training & Enablement Develop operational training materials and business-ready documentation. Enable ITSM, business operations, and configurators with guides and release notes. Drive knowledge transfer to accelerate adoption and reduce production issues. GenAI-Driven Quality Insights Design AI-enabled solutions for automated data profiling and anomaly detection. Leverage GenAI tools (e.g., ChatGPT) for reporting automation and quality insights. Convert outputs into easy-to-understand business communications. Reporting & Intelligence Build release dashboards and quality health reports. Provide predictive insights using GenAI and trend analysis. Deliver executive-ready summaries with recommendations. Collaboration & Stakeholder Engagement Work closely with: Product Managers RTE / STE Quality Engineering & Systems Teams Data Exchange Teams ITSM and Business Operations Required Qualifications Bachelor's degree in Computer Science, Information Systems, Business, or related field. 7+ years of experience in: Quality Engineering Data Systems Release Readiness Governance or QA Leadership Strong understanding of: Data pipelines and ETL flows API integrations Enterprise data platforms Experience with Agile / SAFe / ART frameworks. Proficient in test strategy development and execution. Strong analytical, documentation, and communication skills. Ability to convert technical findings into business-level insights. Comfortable working with senior leadership and cross-functional teams.

Schedule: 6pm to 6am (Overnight) (Will cover onsite interview and relocation cost) Key Responsibilities As the Quality Supervisor, you will oversee and manage a team of Quality Technicians to ensure our products meet the highest standards of quality, food safety, and regulatory compliance. Responsibilities include: 1. Interim Management of Quality Technicians Lead and manage the Quality Technician team to ensure product conformity with customer, company, and regulatory standards Oversee work schedules, timecard approvals, job assignments, training, and time-off requests 2. Internal Audits & Corrective Actions Participate in internal audits to identify areas of non-conformance Lead implementation of corrective actions and ensure timely resolution Track, document, and maintain records for compliance 3. Food Safety & Quality Issue Management Take prompt action to resolve food safety and quality issues Coordinate and support food safety and quality training for plant personnel Oversee the collection and submission of product samples for quality testing Ensure accurate documentation of test results and sample status 5. Quality Improvement Activities Lead initiatives to improve product quality and reliability Collaborate with production shift leaders to ensure quality and consistency Conduct root-cause analysis for product holds or customer complaints and implement corrective actions to prevent recurrence 6. Compliance Reporting Maintain detailed and organized quality control records Prepare and submit reports related to food safety, quality issues, corrective actions, and ongoing improvement initiatives Requirements Proven experience in Quality Control or Quality Assurance, ideally within food manufacturing or another regulated environment Better Process Control Aseptic Certification (preferred, not required) Strong problem-solving abilities, particularly in food safety and quality-control-related issues Experience conducting audits and implementing corrective actions Familiarity with compliance reporting and quality improvement processes

Traveling Energy Marshal - Mission Critical Construction The Traveling Energy Marshal is responsible for overseeing the safety and quality of electrical installations in mission critical construction projects. This role involves traveling to various job sites to ensure compliance with safety standards, quality control measures, and electrical regulations, ultimately ensuring that all work meets the rigorous demands of data center environments. Key Responsibilities Conduct on-site inspections of electrical installations to ensure adherence to NFPA 70E and other safety regulations. Implement quality control processes to monitor the standard of work on construction sites. Collaborate with project managers and construction teams to address safety and quality concerns. Provide training and guidance to site personnel on safety practices and quality standards. Review project plans and specifications to identify potential quality issues before they arise. Maintain accurate documentation of inspections, findings, and corrective actions taken on-site. Qualifications Proven experience in electrical work, particularly in mission critical environments such as data centers. Strong knowledge of safety regulations including NFPA 70E and construction safety practices. Experience with quality control processes and methodologies in construction. Ability to work independently and travel frequently to various job sites. Excellent communication and teamwork skills to effectively collaborate with diverse teams. Certifications in electrical safety and construction management are a plus. Email Your Resume In Word To Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: alec.grice@cybercoders.com Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : AG21-1854587 -- in the email subject line for your application to be considered.*** Alec Grice - Sr. Executive Recruiter For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 05/29/2025 and applications will be accepted on an ongoing basis until the position is filled or closed. CyberCoders is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.

The primary responsibilities include data collection and presentation for regulatory compliance, assistance with site visit preparation for United Network of Organ Sharing (UNOS), Centers for Medicaid and Medicare Services (CMS), and the Joint commission (TJC), and creating action plans through to completion with the Transplant clinical and operational teams. This position works with the Transplant Director of Quality and partners with TUH's Performance Excellence Department and the Department of Regulatory Affairs. Directly responsible for action plans and performance improvement projects to maintain regulatory compliance. Provides training on regulatory requirements and defines Transplant measures of success. Provides input on the performance of transplant team members regarding timeliness and accuracy of data reporting and documentation within regulatory compliance. Education Master's Degree Health care discipline, informatics or related field of study Required Other Graduate certificate in Healthcare Quality and Safety or equivalent Preferred Experience 3 years experience in Transplant and/or Healthcare Quality or Regulatory Required General Experience General knowledge of CMS, TJC and UNOS regulations Required Schedule: Monday - Friday Day Shifts, no on-call, no weekends Our Hospital/Organization Descriptions Your Tomorrow is Here! Temple University Hospital is a nationally respected teaching hospital on Temple University's bustling Health Sciences Center campus. The hospital provides a comprehensive array of healthcare services both basic and complex to patients from around the corner, across the country and around the world. As the chief clinical training site for the Lewis Katz School of Medicine at Temple University, the hospital provides a dynamic environment for high-quality care, teaching, and cutting edge research. Health System Descriptions Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. About Us IB Abel's 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values-Responsible, Integrity, Results-Oriented, Ownership, and Professional-shape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals. IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System. The Opportunity We are seeking an experienced Quality Assurance Manager who is responsible for establishing, implementing, and maintaining the company's Quality Assurance and Quality Control program across all transmission, distribution, substation, and civil construction projects. This role ensures all work is performed to contract requirements, industry standards, and customer specifications. The QA/QC Manager partners closely with Safety, Operations, Project Management, and Field Leadership to drive consistency, reduce rework, promote right-first-time execution, and support a culture of continuous improvement. Key Responsibilities Quality Program Leadership - Develop, implement, and manage the company-wide QA/QC program tailored for utility construction (T&D, substation, and civil); establish quality standards, inspection processes, checklists, and documentation that align with utility customer requirements; and maintain quality manuals, procedures, and work instructions in alignment with industry best practices. Project Support & Field Oversight - Conduct field QA/QC audits, inspections, and work observations to verify compliance with engineered drawings, specifications, construction standards, and work methods; ensure crews understand and apply proper installation practices for poles, structures, conductors, and all related civil work; support project teams in interpreting drawings, standards, and technical requirements; and review and approve ITPs (Inspection & Test Plans), hold points, material submittals, and commissioning documentation. Documentation & Reporting - Maintain accurate QA/QC records, including inspection reports, NCRs (Non-Conformance Reports), corrective actions, testing results, photos, and QA/QC logs; prepare quality reports for leadership and customers, identifying trends, recurring deficiencies, and recommended improvements; and oversee turnover documentation and quality packages for customers. Non-Conformance & Corrective Action - Lead investigations into quality-related issues, rework events, or specification deviations; develop corrective and preventive action plans with field leadership and project teams; and track closure of NCRs to ensure accountability and lessons learned. Training & Continuous Improvement - Deliver training for foremen, line workers, operators, and civil crews on quality standards and proper installation techniques; support onboarding of new field leaders by reinforcing customer-specific construction standards; collaborate with Safety, Operations, and L&D to develop technical guidance, SOPs, and best practices; and lead quality-focused continuous improvement initiatives to reduce defects and rework. Customer & Regulatory Interface - Serve as the QA/QC point of contact for utility clients, inspectors, and third-party engineering firms; coordinate with customer QA reps, attend pre-construction meetings, and support project QC reviews; and ensure compliance with all customer requirements, environmental guidelines, and applicable regulatory standards. Who We're Looking For An acceptable combination of education and/or work experience including 7+ years of experience in electric utility construction (transmission, distribution, or substation) as well as 3+ years in a QA/QC, construction management, or field leadership role. Experience with civil construction related to utility infrastructure (foundations, excavation, concrete, site work). Familiarity with utility standards (e.g., IEEE, NESC, ASTM, utility-specific specifications). Proficient in quality documentation systems such as SiteDocs, Aclaimant, Procore, or similar. Local to Pennsylvania but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate). A “can-do” attitude, strong work ethic, excellent attention to detail, and ability to collaborate effectively with various teams. Why Choose IBA Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company. Flexibility & Autonomy: We empower our team to succeed without micromanagement. Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision. Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure. Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure! Collaboration: A team environment where we work together to solve challenges and celebrate wins. Step Into a Career That Powers the Future! IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy. Responsibilities Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays Supporting Management by performing peer reviews of testing data Supporting Method Performance tracking and trending through data entry, verification, and record archival Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc. Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management Support revision of SOPs and forms to improve workflows in QC Overseeing Housekeeping activities of lab areas Verifying Logbooks are reviewed on time Tracking Lab Notebooks lifecycle Working with EHS to improve Safety Culture in QC Qualifications M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry. Ability to be onsite 5 days per week Deep understanding and experience with working in a GMP environment Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays Ability to work independently and make decisions Leadership experience and project management skills to support a multi-project environment in small biotech. Physical Requirements: Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves Must be able to remain in a stationary position for 50% of the time Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens Constantly communicates verbally with people to exchange information, and give and receive instructions Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials Compensation The expected salary range for this position is $122,000 to $144,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives). EEO Statement A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Job Description Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: The QC Manager is responsible for the management of all quality control testing of raw materials, intermediates and final products (including stability testing) at the West Deptford site. This includes test methodology and documentation required for quality control within government, customer and industrial specifications. The incumbent works closely with quality assurance to ensure that products meet and/or exceed applicable FDA and cGMP standards. This position also works closely with development, production and with customers to ensure that all products meet required specifications. Core Responsibilities: Manage the resources of the Quality Control functions, cGMP systems to ensure products are consistently manufactured and tested according to the cGMP standards. Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed. Manages staff in full compliance with cGMP requirements. Responsible for the Quality Control Department budget and its control. Maintain active customer and governmental contacts concerning technical problems and product compliance and performance. Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc. Assure all testing procedures are written, validated, and maintained. Monitor and direct all quality control activities, which includes but is not limit too, staff scheduling, prioritization of department's work, product team participation, and determination of projects as needed for continuous improvement. Leads quality control investigations and determines root cause to provide effective resolutions, such as CAPA's. Responsible for the overall release/results of materials from the lab. Evaluates metrics to develop/implement efficiency improvements. May perform all work associated with Quality Control Chemist duties to meet the department needs. Qualifications: Required BS Chemistry or related science Minimum of ten (10) years' direct experience in organic analytical/instrumentation chemistry Minimum of seven (7) years direct experience in organic analytical/instrumentation chemistry lab supervision. Preferred Chromatography background Salary Range: $120,000 - $145,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career. How to Apply: At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit **************** to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

**General Description:** Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required. + Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. + Undertake any other duties as required. **Core** **Competencies** **, Knowledge, and Skill Requirements:** + Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related). + Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. + Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Supervisory Responsibilities:** + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time. **Education Required:** Bachelor's Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required. Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred. **Travel:** + Must be willing to travel approximately 10%. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Description With a projected 1,000 cafes in the United States by 2030, Paris Baguette is one of the fastest-growing neighborhood bakery cafés in the world. Our vision is to reestablish the neighborhood bakery café as the heart of the community around the world. Paris Baguette's mission is to bring expertly crafted baked and brewed goods through a warm and welcoming bakery café experience that delivers joy to everyone. If you are someone who has heart, wants to spread joy, nourish community and is ready to rise to the occasion, we are looking for you to join our growing team! WHAT WE ARE HUNGRY FOR The position of Quality Control Manager is responsible for auditing Paris Baguette's standards for all our food, baked products, and beverages while ensuring all-around quality assurance for such products across all of our cafes, with an emphasis on ensuring compliance to company policies and procedures, food safety standards, government regulations, and following up that we are using best practice standards and continually improving programs in place. KNOWLEDGE AND RESPONSIBILITIES Champion adherence of all elements of the food safety and quality roadmap to ensure integration in all cafes. Coach and advise the café teams to ensure an adherence to all Company standards regarding quality. Monitor progress on opportunities and follow up with café teams to ensure corrective actions are taken to address issues where needed. Partner with café production teams and district production managers to provide any necessary feedback to ensure consistency in production standards. Address non-compliance concerns by supporting district managers and district production managers with follow up suggestions for corrective actions needed in cafes based on assessments and visits. Support café production teams and District Production Managers by reinforcing updates and product specification changes as necessary. Audit external suppliers for food safety, food quality, and ingredient specification compliance. Inspect ingredients, packaging materials, and finished products for compliance with company standards and specifications. Help conduct studies to identify problems, potential problems, or continuous improvement opportunities relating to food quality and food safety. Utilize data collection, trend information, and analysis to drive continuous improvement Format and compose weekly, monthly and annual QC quality and food safety reports Performs other related duties and special projects as assigned WHAT YOU NEED TO HAVE Related bachelor's degree, preferably in Food Science, Engineering or Business Administration At least 1-2 years' relevant experience Knowledge of food production processes, sanitation, quality programs Knowledge of food production techniques, food microbiology and food sanitary safety practices and procedures Flexible, adaptive, upbeat, open and visible work style, with a successful track record of supporting operations leaders across a large geographically decentralized portfolio. Passion for people! Dynamic and engaged leader who has a passion for empowering, inspiring, motivating & developing team members and franchisee relationships. Exceptional organizational and communication skills with the ability to effectively balance priorities and deliver results in a fast-paced, ever-changing, and highly entrepreneurial environment. Feedback is a gift! Ability to provide constructive feedback and recognition to every member of the organization, along with Franchisees, to ensure we have an open and transparent culture of high-performance standards. High emotional intelligence with the ability to work with, and support diverse teams by being highly empathetic, intuitive, self-motivated and driven. Teams Win! Has to be a team player who fosters a collaborative and engaged teamwork environment. Being a Brand Ambassador, with an excellent knowledge of and commitment to Paris Baguette's Mission, Vision, Brand Values and Culture. Love of travel! Ability to commute to all current Corporate and Franchise locations, as well as proposed openings. SWEET BENEFITS Competitive compensation Free Cake for your Birthday Medical, Dental, Vision benefits 401K Retirement Plan Paid time off, paid Holidays High Performance Culture

Bristol Bay Construction Holdings LLC (BBCH) is seeking an experienced dual hat Quality Control Manager & Site Safety Officer to join our SES Civil and Environmental team, a subsidiary of BBCH. The primary responsibilities of this position are to coordinate, plan, and supervise subcontractors and/or craft activities to ensure adherence to plans and specifications; enforce site safety and provide contractor quality control. Candidates must have strong organizational and communication skills. This position is based in Folsom, Pennsylvania. Project Scope of Work: Interior and exterior renovation of MCRC Folsom PA, including site work, roofing, finishes, MEPs, and roofing. We are an equal-opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender, or gender identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law. We participate in the E-Verify Employment Verification Program. We are a drug-free workplace. Submittal coordination and review Updating submittal register Inspections of materials and workmanship Army Corps RMS system management and input Safety meetings AHA development and review Review material and safety submittals for compliance Supervise special inspections Verify qualifications Maintain rework/deficiency logs 3 phases of inspection Hold preparatory meetings with the team USACE Quality Control Management EM385 1-1 40hr OSHA 30hr 10 years' experience in construction Experience managing Government projects Proficient in RMS, proficient with Word, Excel, and PDF Experience with Procore Familiar with P6 or Microsoft Project scheduling tools Strong safety background and certs in Fall Protection, confined space, etc. Can pass a background check As a condition of employment, you may be required to pass a pre-employment drug screening and have acceptable references and background check results

Job Description This permanent, full-time position supports the Quality Assurance department. The Quality Control Senior Manager plays a critical role in maintaining and enhancing our commitment to food safety and quality. This hands-on position combines leadership with technical expertise, supporting the Director of Quality Control with administering department operations, validating program CCPs, and participating in audits, while also performing daily functions in the lab. Knowledge of laboratory principles is required. Product testing includes brix, pH, water activity, titrations, viscosities and organoleptic evaluations. Environment is a clean and modern lab working with terrific people. Essential Job and Duties -Develop, implement, and manage quality systems, food safety programs, and regulatory compliance standards (HACCP, GMP, FSMA, SQF, etc.) -Coordinate with the Director of Quality Control to lead internal and external audits, including customer, third-party, and regulatory inspections -Manage record-keeping and reporting systems related to production metrics and regulatory requirements. -Assist with monitoring sanitation programs and environmental testing, ensuring compliance with microbiological and allergen control standards. Promote a clean and safe working environment where respect for coworkers and the consumer is reflected in every procedure. -Maintain and update Operations documents and SOPs -Perform analytical tests on raw materials and finished products -Calibrate laboratory equipment -Work with production to make adjustments to batches in order to adhere to product specifications -Respond to customer questions or concerns in a professional and appropriate manner -Maintain the finished goods retention library -Sample finished product for microbial analysis -Maintain raw material specification documentation and product specification documentation -Maintain finished product specification documentation Requirements -Bachelor's Degree in Food Science, R&D, or related course of study preferred -10+ years of related quality assurance or lab experience -Strong knowledge of HACCP, SQF, FDA, USDA, GFSI, SQF, FSMA, GMP, GLP, required -Food industry experience required -Ability to prioritize and organize ones work load -Ability to work in a team environment as well as individually in an environment with changing priorities -Comfortable working on an active busy production floor among batching and packaging equipment. -Ability to manage time effectively -Maintain proper lab conditions and equipment maintenance -Maintain proper record keeping and perform data entry -Be capable of working in various work settings of the facility including laboratory, office and plant areas -Perform basic math skills -Proficient computer skills, including above average knowledge of MS Excel -Understand and perform scaling/measuring in standard and metric formats -Lifting and carrying up to 50 pounds -Being able to withstand extended periods of time on one's feet -Working and walking in a wet environment

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Reports To: VP, Corporate Responsibility, Safety & Quality Department: Food Safety & Quality The Director of Manufacturing Food Safety & Quality is responsible for leading all food safety and quality programs across a multi-site manufacturing network. This role ensures consistent execution of standards, regulatory compliance, operational readiness, and preventive controls within each facility. With direct oversight of Plant Food Safety & Quality Managers, the Director drives continuous improvement, strengthens raw material quality alignment, enhances detection and prevention systems, and fosters a high-performing food safety and quality culture. This leader is accountable for delivering consistent performance across all sites, proactively identifying risks, analyzing trends, and ensuring timely communication with customers, regulators, and internal stakeholders. The Director is responsible for codifying best practices, aligning processes across facilities, and ensuring that learnings, corrective actions, and preventive activities flow seamlessly across the network. As a key member of the Food Safety & Quality leadership team, this role collaborates closely with Site Directors, Operations, Supply Chain, R&D, and peer FSQ Directors to deliver unified, reliable, and predictable manufacturing performance. The position also represents the organization in customer engagements, audits, and industry forums, and participates in crisis management and incident response activities. Primary Responsibilities Provide strategic leadership for all manufacturing FSQ programs, ensuring consistent, reliable execution across multiple production sites. Lead, mentor, and develop Plant FSQ Managers to strengthen capability, accountability, and technical expertise across the network. Drive standardization of quality processes, raw material criteria, defect frameworks, escalation protocols, and preventive controls across all manufacturing locations. Conduct proactive trend analysis to identify emerging risks and drive timely corrective or preventive actions. Strengthen detection and monitoring systems to reduce defects, foreign materials, microbiological risks, and product variability. Integrate food safety into daily operations and long-term operational strategies in partnership with Site Directors and Operations leadership. Lead root cause investigations, enterprise CAPA programs, and cross-functional improvement initiatives with clear follow-through. Ensure accurate, timely communication to customers regarding FSQ performance, CAPAs, trend data, and preventive measures. Maintain regulatory compliance across all plants, including FSMA, GFSI, GMPs, HACCP, GAP, and customer-specific requirements. Build and sustain an FSQ culture that reinforces ownership, accountability, and proactive risk mitigation. Codify and share best practices across sites to accelerate improvements and raise system maturity. Represent the organization in customer meetings, audits, and industry events. Support crisis and incident management activities, ensuring rapid escalation, investigation, and resolution. Qualifications 10+ years of FSQ leadership experience in fresh-cut, produce, food manufacturing, or multi-site operations. Bachelor's degree in Food Science, Microbiology, or related field; advanced degree preferred. Strong knowledge of GMPs, HACCP, FSMA, GAP, and GFSI requirements. Proven experience leading multi-site teams and building high-performing FSQ organizations. Demonstrated ability to analyze data, identify trends, and implement preventive strategies. Strong communication skills with experience interacting directly with customers and regulatory bodies. Demonstrated success driving standardization, best practice replication, and cultural transformation across multiple manufacturing sites. Essential Job Functions Ability to climb stairs Ability to lift up to 25 lbs Ability to sit at a workstation for extended periods

This position will lead and participate in projects for the integration of new products into systems that impact the US Pharm Local Operating Company (LOC) and Deliver organizations. Open to candidates located in Horsham PA or Titusville NJ. Responsibilities: Key responsibilities include, but are not limited to: Projects (100%) Provide project leadership and support related to quality systems for US Pharm CQ and US Deliver initiatives. Complete GMP documentation to ensure compliance. Track completion of project deliverables. Coordinate and collaborate with project team members. Propose process improvements. Provide routine project updates. Perform additional tasks as needed to support project deliverables. Others: Execute compliance activities on behalf of team leadership, including but not limited to the creation and revision of regional and local procedures and/or work instructions. Escalate appropriate issues to management. Make quality decisions based on assessments of compliance risks, balanced with overall business needs. Drive strategic initiatives for both CQ and distribution centers. Ensure strategies are implemented and closed out in a compliant and timely manner. Experience: Minimum of 3 years' experience in the Medical Device, Pharmaceutical, or Consumer Products industry. Experience working in a highly regulated industry. Proven experience leading projects and influencing team members to achieve results without direct supervision. Strong written and verbal communication skills, with the ability to take initiative independently as well as collaborate as part of a team. Demonstrated problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills. Excellent communication and presentation skills. Strong change management, collaboration, and influencing skills to effectively partner across functions. Ability to work under tight timelines and maintain customer focus. Must be able to manage and provide leadership across multiple sites. Advanced proficiency in PowerPoint and Microsoft Excel, including VLOOKUPs and pivot tables. Demonstrated flexibility to handle complexity and multiple initiatives. Proven ability to successfully partner and collaborate with business partners outside of Quality. Experience interpreting compliance requirements and regulations. Preferred Skills and Experience: Project Management certifications. Understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485. Understanding of Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ), and associated report writing. Familiarity with Comet. Skills: Project Management Biomedical Industry Pharmaceutical Regulatory Compliance Education: Bachelor's/University degree. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Azhar Email: **************************** Internal Id: 25-53768

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

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.