About us At Cooper University Health Care , our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description This person performs audits and manages the registration work queue errors. This person will work with the front-line staff doing one/one training, coaching and informational training emails using the results of the WQ errors and Audits. This position contribution to employee engagement, improved financials through reducing denials and rework Experience Required * 3 years experience in a Contact Center environment with demonstrated experience in both learning and quality capacity preferred * Teaching or training experience is preferred; training experience within a medical or Healthcare environment a plus * Experience in or knowledge of any of the following is preferred: Central Scheduling, Medical Terminology, Insurance Verification, Registration, Scheduling, Authorizations, Referrals * Must be able to articulate and demonstrate an instructional/informational design methodology * Must be knowledgable of performance measurements, quality initiatives, coaching and mentoring, staff development, and the unique demands of frontline staff Education Requirements * High School Diploma Required * Bachelors preferred Special Requirements * Must be learner-focused, with the ability to develop targeted materials based on learner preferences, characteristics, competencies * Strong instructional design abilities (via experience or education) especially related to needs assessment and customized development for varied learners preferred; knowledge of performance based instructional methodology is preferred * Must have superior writing skills related to informational and instructional material, including the ability to present content in a non-paragraph and linear way. Experience with graphic design is a plus * Must be a high-performing and facile PC user and an expert in the Windows Suite (specifically PowerPoint and Word). Experience with E-Learning and Alternative Media a plus * Must possess solid classroom delivery skills related to motivating and capturing the attention of adult learners; must display high energy, confidence, a sense of fun, and the desire to provide a unique and memorable learning experience. A sample presentation will be required. * Must be motivated, decisive, and a problem solver with excellent time management, leadership aptitude and organizational skills * Must be a team player * Must have demonstrated experience in communicating effectively with all levels of management * Must be able to work varied hours as business needs change (i.e., possible evening and weekend hours)
$58k-84k yearly est. 2d ago
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Manager Quality Systems & Compliance
Piramal Pharma Solutions
Quality engineer job in Sellersville, PA
Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products.
The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs.
Key Responsibilities
Quality Systems Leadership
Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms.
Ensure effective use of quality systems to support site compliance and continuous improvement initiatives.
Review and approve quality system records, including deviations, CAPAs, change controls, and training records.
Training Program Management
Oversee all site training activities and ensure compliance with regulatory and internal requirements.
Partner with department heads and SMEs to develop, implement, and maintain training curricula.
Provide guidance and training to end users on quality systems and processes.
Document Control
Manage the site SOP program and overall document control lifecycle.
Oversee document management activities, including Master Batch Records and protocols.
Compliance & Governance
Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards.
Provide quality system metrics on a weekly, monthly, and quarterly basis.
Manage Annual Product Reviews (APRs).
Oversee complaint, FAR, and recall management processes.
Manage Quality Technical Agreements (QTAs).
Audit & Supplier Management
Lead the Supplier Management Program.
Manage internal, external, client, and regulatory audits.
Actively support regulatory inspections and client audits.
Data Integrity & Computer Systems
Serve as Site Data Integrity Compliance Officer (DICO).
Manage the site Data Integrity Program.
Oversee the Computer System Validation (CSV) program.
Support implementation and upgrades of electronic systems.
Continuous Improvement
Collaborate with the corporate quality team to implement global policies and procedures.
Support site quality improvement initiatives and special projects.
Ensure adherence to site safety standards.
Perform additional Quality Systems & Compliance activities as assigned.
Required Qualifications
Education
Bachelor's degree or higher in a scientific, quality assurance, or technical discipline.
Experience
Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry.
At least 5 years in a supervisory or managerial role.
Technical & Functional Skills
In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA).
Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing.
Hands-on experience with eQMS platforms (DMS, LMS, eBMR).
Proven experience in audits, supplier management, and data integrity.
Excellent organizational, communication, and cross-functional collaboration skills.
Proficient in Microsoft Office and standard business systems.
Ability to manage multiple projects and priorities simultaneously.
$88k-132k yearly est. 4d ago
Process Engineer - Contract Development Manufacturing
Veranova
Quality engineer job in West Deptford, NJ
Discover Veranova:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse 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 Process Engineer is responsible for the design and implementation of elements of new or improved processes as they are transferred from development to production.
Core Responsibilities:
Collaborate with cross functional teams to develop safe, efficient, practical and commercially viable processes to generate a consistent quality API supply fit for its intended use, with essential considerations given to optimizing process yields, turnaround times, and productivity.
Lead process improvements efforts which improve yields and/or lower production costs, enhancing the overall efficiency and cost effectiveness of the Pharmaceutical Materials production processes.
Design and conduct a variety of experiments or plant trials to define process conditions that match or improve plant capabilities to run commercial processes.
Contribute in pilot and validation runs in the manufacturing plant
Collaborate with Project/Facilities Engineering in capital projects during front-end design (URSs, PFDs, M&E Balances), PHAs, design reviews, commissioning, start-up and operator training
Lead troubleshooting efforts related to processing and process equipment problems while gathering relevant information and compiling necessary reports.
Write and review Batch Records, SOPs, Process Validation Protocols, and other technical reports
Collaborate with the EHS group on environmental, health and safety related aspects of new processes and process modifications; performs related emission calculations
Develop process performance tracking procedures and analyses existing data for optimization potential
Qualifications:
Required
B.S. in Chemical Engineering or equivalent technical degree required.
Minimum of 3 years manufacturing or process engineering experience in Pharmaceuticals required.
Knowledge of commonly used equipment, technical concepts and procedures within bulk API batch manufacturing.
Advanced knowledge of Microsoft Office Products (Word, Excel and PowerPoint) required.
Team oriented and able to work efficiently in a project driven environment.
Strong verbal and written communication and presentation skills.
Excellent organization skills and ability to prioritize and multi-task.
Knowledge of FDA/cGMP guidelines and practices.
Strong statistical analysis skillset.
Strong Failure Mode and Effect and Root Cause analysis skills.
Salary Range: $90,000 - $110,000 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 welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
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.
$90k-110k yearly 3d ago
Process Engineer - Wire Bonding / Hermetic Sealing
Avo Photonics 3.8
Quality engineer job in Fort Washington, PA
Avo Photonics is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype and produce next generation products for a diverse range of markets including environmental, medical, military, industrial, aerospace, and communications.
We seek a diligent, dedicated and meticulous person who will help to further our success and reputation in the industry through world-class customer service. The successful candidate must plan his/her own work schedule, keep multiple records, be self-motivated, maintain a professional presence, and have the desire to take ownership of projects.
This role may be suitable for a junior or senior engineer.
Specific:
Develop high yield, cost efficient, manufacturable processes as appropriate for target production volumes
Act as end-to-end owner of key equipment such as die bonders, wire bonders, seam sealers, laser welders, etc
Provide subject matter expertise for process development on equipment you own. Understand tool capability, process viability, and material selection
Own maintenance, upgrade, and repair of equipment you own. Ensure minimal production downtime through regular preventative maintenance. Understand the function of the tools inside and out, in order to resolve issues as quickly as possible
Provide data-based evidence that developed processes meet product requirements through design of experiments and statistical process control (within material availability)
Generate documentation of the process development lifecycle for each project; contribute to business knowledge repositories for fixtures, materials, and process parameters
Create work instructions and provide training on resultant processes to Product Engineering and Manufacturing personnel
Guide the design of fixtures required to assemble products
Recommend and implement new equipment and techniques to improve process capabilities
Requirements:
B.S. in Physics, Material Science, or relevant Engineering field
5 years experience with precision optical alignments or programming automated manufacturing equipment
5 years of experience in design of experiments and statistical process control.
3 years of manufacturing experience
Proficiency with software-based logic, such as programming, Matlab, etc.
Excellent communication skills and willingness to learn
Avo Photonics offers competitive salaries and a comprehensive benefits package.
Equal Opportunity Employer: Avo Photonics is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee of Avo Photonics by any method without a valid written contract in place with Avo Photonics will be deemed the sole property of Avo Photonics. No fee will be paid in the event the candidate is hired by Avo Photonics as a result of the referral or through any other means.
$63k-84k yearly est. 5d ago
Quality Assurance & Control Manager (Electric Utility Construction)
IB Abel Inc. 3.5
Quality engineer job in Philadelphia, PA
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.
$80k-108k yearly est. 47d ago
Manager - Quality (Value Add Services)
Wesco 4.6
Quality engineer job in Cranbury, NJ
As the Manager - Quality, you will manage the inspection and testing of materials, parts, and products to ensure adherence to quality standards. You will propose corrective actions to improve compliance with quality specifications and recommend new or improved quality control methods, procedures, and standards. You will direct the activity of the quality department to ensure all customer requirements, product specifications, and process outputs will support current business plans. You will direct improvements in the quality management system to meet customer expectations and grow the business model.
**Responsibilities:**
+ Manage and execute the Quality Management System
+ Direct the activities of the quality department
+ Manage a corrective action process to address quality issues
+ Lead communication with customers to resolve questions and define corrective actions
+ Develop plans for the Quality Management System to expand and support business growth
+ Report the performance of the operation using statistical processes
+ Devise ways to continually improve the quality control process to ensure higher-quality goods
+ Keep accurate documentation and performing statistical analysis
+ Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures
**Qualifications:**
+ Bachelor's Degree
+ 5 - 8 years related work experience
+ 5 - 8 years supervisory experience
+ In-depth knowledge of quality control procedures and legal standards
+ Strong attention to detail, observation, organizational and leadership skills
+ Knowledge of mathematics, data analysis and statistical methods
+ Ability to travel up to 50%, including domestic and international travel
**Working Environment:**
+ General Office - Work is generally performed within an office environment, with standard office equipment. Lighting and temperature are adequate and there are no hazardous or unpleasant conditions caused by noise, dust, etc.
+ Driver - Work is generally performed in moving vehicle. Driving required for an extended period of time with frequent stops and starts. Can be exposed to outdoor weather conditions.
**Physical Requirements:**
+ Work is physically strenuous and workers are required to lift heavy packages up to 50 pounds
+ Work may require excessive bending or stooping
+ Employee required to walk long distances repeatedly throughout the day
+ Employee required to climb ladders
+ Employee required to use hand tools\#LI-CP1
At Wesco, we build, connect, power and protect the world. As a leading provider of business-to-business distribution, logistics services and supply chain solutions, we create a world that you can depend on.
Our Company's greatest asset is our people. Wesco is committed to fostering a workplace where every individual is respected, valued, and empowered to succeed. We promote a culture that is grounded in teamwork and respect. With a workforce of over 20,000 people worldwide, we embrace the unique perspectives each person brings. Through comprehensive benefits (**************************************************************************** and active community engagement, we create an environment where every team member has the opportunity to thrive.
Learn more about Working at Wesco here (******************************************************************* and apply online today!
Founded in 1922 and headquartered in Pittsburgh, Wesco is a publicly traded (NYSE: WCC) FORTUNE 500 company.
_Wesco International, Inc., including its subsidiaries and affiliates ("Wesco") provides equal employment opportunities to all employees and applicants for employment. Employment decisions are made without regard to race, religion, color, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, or other characteristics protected by law. US applicants only, we are an Equal Opportunity Employer. _
_Los Angeles Unincorporated County Candidates Only: Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act._
$77k-113k yearly est. 10d ago
Food Safety Quality Assurance Manager Protein (2nd Shift)
The Clemens Food Group 4.5
Quality engineer job in Hatfield, PA
Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager.
In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants.
Shift Details
Shift starts at 3:00 PM and runs for 9 hours
As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs
On-call approximately one out of every four weekends
The Impact You'll Make
You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance.
What You'll Do
Lead and develop a second-shift FSQA team (multiple supervisors and techs)
Be the point of contact for USDA, customer complaints, and urgent investigations
Review and act on trend data to improve quality and reduce CPMs
Collaborate cross-functionally with Ops, R&D, and Sanitation
Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends)
Prioritize food safety and people leadership at every turn
What Makes This Role Exciting?
You're the top FSQA decision-maker on your shift
Gain experience in a high-capacity, 1.3M sq. ft. protein facility
Every day brings new projects, challenges, and growth moments
Room to grow-this role is a stepping stone to FSQA Manager
What We're Looking For
Proven FSQA leadership, meat/poultry/seafood industry required
Proven ability to lead teams and manage performance
Strong background in USDA, HACCP, audits, and corrective actions
Comfortable with ambiguity, fast pace, and solving complex floor issues
Skills & Mindset
High initiative: confident in making decisions without constant direction
Project-focused: can organize chaos into action plans and results
People-first: builds trust, holds people accountable, and develops others
Strong communicator: connects across functions, listens well, and presents data clearly
Your Future at Clemens
This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA.
Application Note:
Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim.
#LG-AG1
Keywords
Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager.
#LI-AG1
$69k-100k yearly est. 60d+ ago
Quality Manager consultant
Ayr Global It Solutions 3.4
Quality engineer job in Cherry Hill, NJ
AYR Global IT Solutions is a national staffing firm focused on cloud, cyber security, web application services, ERP, and BI implementations by providing proven and experienced consultants to our clients.
Our competitive, transparent pricing
model and industry experience make us a top choice of Global System
Integrators and enterprise customers with federal and commercial
projects supported nationwide.
Subject: Quality Manager consultant
Location: Cherry Hill, NJ
Duration: 6+ months plus
US Citizen, GC is preferred but will accept H1.
Qualifications
Job Description: Quality Manager consultant
Responsible for leading testing and quality process for IT functions supporting car automation.
Responsible for regression testing plan and execution.
Work with business to ensure integration requirements for IT platforms are properly established and
executed.
Responsible for unit and integration test plans for IT applications.
Ensure quality metrics are established and achieved in partnership with the business owners.
High touch interaction between business and IT team members.
Additional Information
If anyone might be intersted please send resumes to kmarsh@ayrglobal (dot) com or you can reach me direct at **************
$77k-112k yearly est. 60d+ ago
Clinical Quality Manager
Artech Information System 4.8
Quality engineer job in Collegeville, PA
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
The correct title for this position is Clinical Quality Manager. Role Description The Clinical Quality Manager (CQM) is responsible for driving Asset and Study level quality management for specific assets primarily in the Alliance Partner (AP) model by maintaining 'quality' line-of-sight from Asset to Clinical Investigator Site level.
• With this focus, the CQM role brings deep knowledge for asset- and study-level quality across clinical trial business process areas. In partnership with the Dev Ops Asset Lead and BU Clinical Lead, the CQM will ensure study level quality oversight, manage relevant Asset and Study level quality issues, and will be instrumental in ensuring that Asset and Study level information is appropriately incorporated within the GCP QMS. Act as point person to stakeholders and asset teams for asset and study quality risk management and quality issues management.
• CQM may also continue to provide additional centralized services as described below as necessary. Responsibilities As CQMs are assigned to specific Asset, responsibility includes: Facilitate IQMP Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) Facilitate study-level quality risk management activities (including IQMP activity)
• Drive consistent implementation of IQMP across study-teams Facilitate IQMP development to ensure that study teams: Identify factors that are critical to quality and pre-specify appropriate quality metrics Identify high priority risks to quality and prospectively implement appropriate mitigation plans
• Facilitate IQMP implementation, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQM team Provide feedback to IQMP BPO to continuously improve IQMP approach Quality Gate and/or Quality Compliance Assessments Perform quality gate assessments (e.g. quality, completion or compliance assessment of key quality elements (e.g. prior to study start-up, during conduct phase, and study closeout)
• Perform asset or study-focused quality compliance assessments Track compliance or performance against expectations, and manage outcomes Asset Clinical Quality Management Facilitate study-level quality risk management activities (including IQMP activity) Maintain comprehensive portfolio of quality issues across Asset Provide quality management / operational expertise Review quality reports and metrics for asset/study implications and remediation needed; to identify useful knowledge to apply/share cross-functionally IQMP PSQRV visit information for trends across asset Significant deviations/qualifying quality issues (QQI) across asset
• Audit/Inspection Metrics Audit and/or CAPA Trend reports Protocol Deviations Metrics and Trends Guide asset/study team on appropriate quality remediation actions, facilitates remediations, and tracks/ensures completion in close collaboration with DevOps Asset Lead and BU Clinical Lead (e.g. remediation for pervasive cross-asset protocol deviation issues)
• Ensure timely progress and completion for quality activities for which study teams/Alliance Partner are responsible per Clinical Trial Process Quality Standards (CTPQS): (e.g. Audit CAPA completion, study level quality issue action tracking, inspection readiness) Participates on QQI teams to provide guidance on actions to address quality issues (e.g. issuance of Protocol Deviation Alert Letters (PDAL), or actions to address QQI) May attend governance meetings and provide knowledge/trend information as appropriate
• Perform Root Cause Analysis (RCA) for ad hoc asset quality issues Participate and guide team with Inspection conduct and response activity Maintain line-of-sight to asset quality issues where studies within asset are in multiple models (e.g. AP model, Maintained portfolio) Escalation, Communication, and Governance Guides asset/study team on appropriate escalation pathways Communicates/Escalates Asset / Study quality issues to: Asset-level roles (e.g. DevOps Asset Lead, Clinical Lead) Governance committees as necessary (e.g. QCC, QOC) BPOs for process level issues Alliance Partner Quality group/roles for potential qualifying quality issues as applicable Communicates study team continuous improvement feedback on business processes to BPOs Communicates key quality information (e.g. inspection/audit learnings) across asset/study teams and may serve as asset quality expert and liaison to relevant governance meetings
• Lead or participate in quality-focused meetings for Asset Teams Perform other quality management related or oversight tasks as assigned CQMs may be responsible to provide other CQM centralized services which may include: Quality Compliance Assessments Lead / Contribute to Quality and Compliance Assessments (QCA) planning, conduct and report-out Line Compliance and SOP Review Coordinate and may manage the DevOps Compliance Plan (ADM02); ensure CTPQ training compliance Contribute to the review of new and revised SOPs to determine impact on DevOps business and compliance capability Audit Coordination Point of contact within DevOps and for internal audit groups for process audit planning, conduct and response support; may serve as DevOps/Clinical Audit Coordinator; track Dev Ops / Clinical process audit CAPAs; provide Audit Schedule Root Cause Analysis Facilitation May lead or participate in Root Cause Analysis for ad hoc requests Inspection Readiness Develop and lead strategy for and/or provide Study Team Inspection Readiness (IR) guidance and support; leads teams through pre-submission IR deep-dive Act as CQM Inspection Readiness contact for study teams via the CPM line Inspection
• Support Acts as lead point of contact or supports the lead/main CQM point of contact within DevOps and for MQA when regulatory inspections are announced Coordinates or supports coordination of resources within DevOps/Clinical to ensure successful inspection outcomes and CAPA management for inspection commitments, communicates inspection progress and needs to DevOps/Clinical stakeholders QQI/CAPA Management: Acts and/or supports CAPA Mgmt lead as business line quality group for CAPA Management of Dev Ops / Clinical CAPAs .
• Ensures or supports compliance with CAPA process QQI Case Management o Will or may function as QQI Case Lead: management for Significant Deviations, including investigation/root cause analysis and action development, tracking, and documentation Qualifications Training & Education Preferred: Degree in one of the disciplines related to drug development or business. Advanced or comprehensive knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Prior Experience Preferred Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management Strong influencing skills with ability to influence a broad range of global stakeholders. Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization Experience of drug development across one or more business lines Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries Ability to work successfully with internal and external partners
• Excellent communication skills adaptable to meet the needs of diverse stakeholder groups Experience of conducting, managing or participating in an audit and/or inspection process Record of achievement and delivery for personal and team goals Ability to balance and prioritize a diverse and demanding workload Works independently and proactively set own work agenda with minimum guidance Competencies: Advanced or comprehensive knowledge in clinical trial development Able to use metrics and related data to determine where quality issues may exist and address appropriately Advanced or comprehensive experience in Quality areas such as: Quality management, quality compliance assessments, audit, inspection, compliance, CAPA management, and inspection readiness fields Knowledge of Pharmaceutical process in these areas
• Project Management skills/experience Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses Knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines Knowledge of Pharmaceutical SOPs and processes Ability to implement strategies using coordinated and transparent metrics to track and manage compliance Ability to lead cross-line global initiatives or root-cause analysis for quality related process improvement"Facilitate IQMP
• Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) " Quality Gate and/or Quality Compliance Assessments Asset Clinical Quality Management " Advanced or comprehensive clinical trials experience, especially operational processes and/or systems.
Qualifications
Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management " Skills Skills Skills:Category Name Required Experience Areas of Expertise Compliance Yes 6 + Years Technical Skills Quality Audit Reports Yes 6 + Years Additional Skills:Advanced knowledge of Clinical Trial development required. Minimum of Bachelors Degree required. Advanced degree preferred.
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
$78k-108k yearly est. 60d+ ago
Quality Technician - Aseptic
Puratos 4.7
Quality engineer job in Pennsauken, NJ
The Quality Technician in microbiology aseptic processes ensures products meet microbiological standards and are manufactured in a sterile environment. This role monitors quality assurance standards and encourages the team to consistently deliver excellent results. The Quality Technician is responsible for executing best practices, goals, and established standards for the team.
Primary Responsibilities
* Perform tests to identify harmful microorganisms, maintain a sterile environment, and ensure regulatory compliance
* Document and analyze test results following good laboratory practices for microbiology and quality control laboratories
* Identify and address production issues, contributing to corrective action
* Inspect work daily, maintain cleanliness, organize supplies, and assemble sterile products using aseptic technique
* Handle biohazard spills, train new hires, and demonstrate the use of cleaning chemicals
* Uphold quality standards, follow GFSI, HACCP, and GMP guidelines, and participate in food safety inspections
* Support sanitation operations, monitor performance, and provide report
* Address customer complaints, conduct audits, and contribute to quality assurance improvements
* Promote continual improvement and collaborate on cross-functional projects
* Perform routine environmental monitoring within cleanrooms and production areas to detect microbial contamination
* Conduct microbiological assays on raw materials, in-process samples, and finished products using various techniques
* Accurately record and interpret test results, maintaining detailed documentation of activities, including deviations, investigations, and corrective actions
* Participate in investigations for out-of-specification (OOS) results, deviations, and complaints related to microbiology testing
* Ensure proper calibration and maintenance of laboratory equipment used for microbiological analysis and QC testing
Prior Knowledge/Experience
* Bachelor's Degree in Microbiology, Biology, or related field
* 1-3 years of experience in quality; food processing experience preferred
* Strong understanding of aseptic techniques and microbiology principles
* Experience with various microbiological testing methods, including plate counting, membrane filtration, and rapid microbial detection
* Proficiency in data analysis, documentation, and recordkeeping
* Excellent attention to detail; ability to work independently and in team environments
* Familiarity with GMP regulations and quality systems
* Ability to utilize provided PPE - safety glasses, ear plugs/muffs, bump caps, dust masks, company uniform, safety shoes
* Ability to be respirator certified if required
* Physical ability to sit, stand, walk, climb, stoop for up to 8 hours; lift 55 lbs consistently; lift/hold objects overhead for extended periods
* Ability to climb and work on a 40-foot extension ladder for extended periods as needed; work at heights up to 50 feet
* Ability to maneuver and work in confined areas with variations in temperature, humidity, and air quality
The following common allergens are processed in our facilities: wheat, eggs, dairy, and soy.
Looking for a Career for Good?
We offer a competitive compensation and benefit package, designed to promote a Happier, Healthier You which includes:
Compensation:
* Compensation for this role is hourly and will be based on your experience, skills, and location, with a typical range between $24.69/HR and $30.87/HR.
* This role is eligible for a targeted annual bonus equal to $3500. Final bonus payouts are determined by both individual and company performance.
Benefits:
* Medical coverage starts the first of the month-no waiting period
* Immediate 401(k) eligibility with fully vested matching contributions
* Over 5 weeks of paid time off in your first year
* Free life coaching, onsite health exams, and 24/7 access to Registered Nurses
* Lifestyle Spending Account
#LI-DNI
Apply now
* Apply Now
* Start applying with LinkedIn
$24.7-30.9 hourly 13d ago
Quality Technician
Almag Aluminum
Quality engineer job in Pennsauken, NJ
The Quality Technician's role will be seen as pivotal in our efforts to drive at-source quality at ALMAG. The role requires the individual to support new product introduction, provide quality training, support, and to work collaboratively with various teams to develop standard work and ensure compliance.
DUTIES AND RESPONSIBILITIES
The quality technician's primary responsibility is to positively support the various departments in assuring that the requirements of the customer and quality management system are being met throughout each department. Additionally, the quality technician contributes to the continuous improvement of Almag's quality system.
The duties and responsibilities of the Quality Technician are detailed below, but not limited to the following:
Supporting the New Product Introduction process by assuring new customer requirements are understood and achieved.
Responsible for performing audits of various departments to ensure that the QMS requirements are being met.
Communicate new product status, its performance based on data, and provide samples and feedback to the respective departments with continuous improvement approach in mind.
Responsible for collecting samples as required for various customer and internal requirements.
Responsible for tracking and supporting Quality Containment processes for nonconforming product in all departments.
Responsible for supporting production team in achieving customer requirements through training, auditing, and development of standard documents.
Provide direction and support to any special sorting if needed, with the focus on accuracy and efficiency of sorting.
Perform product testing for mechanical properties.
Support team lead and shift supervisors to determine criteria for acceptance or rejection when there is uncertainty.
Provide direction to the team if clarification is required for WO notes or requirements.
Perform other related duties as assigned.
Requirements
MINIMUM QUALIFICATIONS
Education/Experience
At least 3 years' experience in quality, working in manufacturing environment.
ASQ Certified Quality Technician (CQT) would be an asset.
Certified Internal Auditor would be an asset.
Technical Skills/Competence
Excellent teamwork and collaboration across departments and within teams
Work Efficiently
Flexibility/Adaptability to meet customer business requirements.
Communicate clearly and effectively, verbally and in writing.
Must be able to read and understand engineering drawings.
Basic knowledge of GD&T would be an asset.
Ability to work and make decisions independently.
Good mechanical aptitude and attention detail.
Must be competent in the use of measuring instruments i.e. Calipers, micrometers.
Basic proficiency with MS-office (Excel, Word, PowerPoint).
Fork Lift Certified
Benefits
Profit Sharing
Education Assistance Program
Social Events
Safety Shoe and Glasses Allowance
Internal Growth and Development
Health and Dental
Life and AD&D
Vision
Critical Illness Insurance
Long Term Disability
$36k-55k yearly est. Auto-Apply 60d+ ago
Web Engineer with healthcare industry experience.
Syncreon Consulting 4.6
Quality engineer job in Blue Bell, PA
We provide Recruitment and Staffing services to many industries and domain through our innovative and customized solutions and passionate commitment to research. Ability to understand the hiring strategies, availability of talent and compensation benchmarking makes us proud hiring partner for various industries. We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies
Job Description
Required Skills
-
• 5+ years of relevant software engineering experience.
• 5+ years of healthcare industry experience.
• 5+ years' experience with:
o C#, ASP.NET, MVC
o JavaScript, CSS, HTML
o Source Control
o Use of 3rd party libraries (e.g., Telerik)
o JSON, AJAX, JQuery, Bootstrap
o WCF, .NET (3.5-4.8), Entity Framework
o SQL/T-SQL: queries, tables, views, stored procedures (SPROC)
• Strong knowledge and application of SAFe Agile practices (preferred).
• Proficiency working with large data sets.
Regards,
Mohammed ilyas,
PH - ************ or Text - ************ or you can share the updated resume at Mohammed@vtekis. com
Additional Information
All your information will be kept confidential according to EEO guidelines.
$59k-76k yearly est. 21h ago
Continuous Improvement Engineer
Double h Plastics Inc. 4.3
Quality engineer job in Warminster, PA
MAIN OBJECTIVES:
Provide support to the Continuous Improvement Engineering Manager in establishing the collection, recording, development, and optimization of KPI metrics for data delivery and analysis, targeted improvement initiatives, cross-functional training, and technical support for the creation of new and the improvement of existing processes. Assist in supporting a culture of Lean Manufacturing in the operations at all Double H facilities through research, observation of production performance, and investigation for opportunities of improvement and established standards.
Assists in collection, documentation, and creation of monthly tracking reports for plant metrics; including production levels, downtime, defect rates, cycle times, OEE, and COPQ. Will complete analysis in performance variances in the aforementioned metrics, using lean manufacturing investigative tools and prepare corrective actions with reports. Maintain and update plant metrics dashboards in Power BI or a similar platform. Assist in the composing of standard work instruction documentation for all positions and assists HR teams in developing and maintaining training matrix for new employee onboarding.
PRIMARY DUTIES AND RESPONSIBILITIES: Follow and promote the company's safety-first culture through proper execution and monitoring of safety procedures; including the use of all safety equipment, personal protective gear, and safety glasses (where applicable). Stops and reports ALL unsafe activities immediately.
Assist Continuous Improvement Manager in effective process evaluation, root cause analysis, corrective actions and failure analysis. Monitor scrap and waste levels for all lines and help drive reductions in waste to increase output and maximize uptime.
Project research and data recording, including: time-studies, work flow analysis, machine metrics, ergonomics and employee movements.
Develop automated spreadsheets, interactive user-forms, and dashboards using Power BI or similar tools.
Track metrics for line startup, changeovers, preventative maintenance, safety initiatives, and employee performance to evaluate the effectiveness of process changes.
Author and edit standard work instructions and single point lessons. Work with plant managers or teams to develop and train employees.
CRITICAL KPI'S:
C andidate will be measured on completion, quantity, and quality of assigned work.
Maintenance of on demand data and accuracy of the data presented.
Generation of cost saving and waste removal projects, production increases, scrap reduction and performance improvement of the plants.
Ability to work across all plants and managers to a satisfactory experience and performance level.
QUALIFICATIONS:
Education:
Associates or Bachelor's Degree in Engineering (Industrial, Manufacturing, Mechanical, Plastics, or Electrical)
Required knowledge:
Manufacturing process control
Lean Manufacturing or Six Sigma
Engineering principles (Math and Mechanical aptitude)
An ideal candidate will be/have:
Self-motivated - able to complete tasks with little assistance, choosing to do things the right way even when it takes longer or there is pressure to take shortcuts.
Extremely organized with high attention to details.
Strong written and oral communication skills.
Bold and take the initiative to act.
2-3 years of manufacturing experience.
Creativity when data collecting and problem solving.
Good interpersonal skills - comfortable speaking with, training, and interacting with people at all levels of the organization on a daily basis.
Inclusive of all ideas, and able to navigate multi-cultural/multi-language teams.
Skills/Abilities:
Strong MS Excel skills at the complex formula, advance charting, pivot table level. Visual Basic or other coding language a plus.
Strong skills in MS Teams, Power BI, DOMO or similar visual display software.
Knowledge of Pareto, 5-Why, 8D, Ishikawa (Fishbone) diagram, root cause analysis.
#IND1
$59k-74k yearly est. Auto-Apply 40d ago
Process Engineer
Veolia 4.3
Quality engineer job in Trevose, PA
Veolia is a global leader in environmental services, operating across all five continents with nearly 218,000 employees. Specializing in water, energy, and waste management, Veolia designs and implements innovative solutions for decarbonization, depollution, and resource regeneration, supporting communities and industries in their ecological transformation. Within this framework, Water Tech brings together a dedicated team of experienced professionals committed to tackling the world's most complex challenges related to water scarcity, quality, productivity, and energy. Together, we pursue a shared mission to create a more sustainable future.
Job Description
Veolia Water Technologies, Inc. (VWT) is currently seeking a Process Engineer, Anaerobic & Aerobic Digestion for our Trevose, PA or Cary, NC office.
The Process Engineer is focused on biological processes, aerobic and anaerobic, complete wastewater system designs, service and startup for industrial wastewater treatment in a project driven business unit.
Responsibilities include:
* Complete and detailed system design, including mass balances, consumables, Process Flow, P&IDs, System Control narratives, O&M development, and equipment selections
* Work with the sales team in securing full scale industrial jobs, including site inspections and customer technical presentations
* Work with engineering team to assure proper execution of system design
* Performs on site start ups, performance testing and troubleshooting on executed full scale facilities
* Supervises and organizes pilot and lab work as necessary for the project and product development
* Interact with vendors to specify equipment and obtain pricing
* Run proprietary Veolia process design models for anaerobic & aerobic system design
* Reports progress of the process department to upper management
* Provide aftermarket services for customers including fulfilling service contracts, customer data review, and providing process advice to customers
Qualifications
* A Bachelor's Degree in environmental or chemical engineering or equivalent
* 5 years experience in the field of biological process engineering (Aerobic and/or Anaerobic) related to wastewater treatment preferred
* Experience in complete wastewater system design desired
* Field commissioning and/or start-up experience desired
* Proficiency in Microsoft and Google Suites
* Autocad proficiency desired
* Quality writing & communication skills
* Laboratory experience for bench pilots & testing desired
* Travel may be up to approximately 30%
Additional Information
We are 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 protected veteran status.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
$61k-79k yearly est. 60d+ ago
Standards Bioprocess Engineer
GSK
Quality engineer job in King of Prussia, PA
The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle.
The MSAT standards bioprocess engineer will lead and support the creation, implementation and maintenance of technical standards for bioprocess operations for use at our Upper Merion commercial site. You will work with operators, engineers, quality and global standards teams to simplify processes and improve consistency. We value clear communication, practical problem solving and a willingness to learn. This role offers career growth, visible impact and a chance to help GSK unite science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Develop, review and maintain clear procedural and technical standards on contamination control, single-use systems, cleaning validation, lifecycle management, leachable and extractables, and cell banking.
Serve as a technical enterprise leader across the Upper Merion site, to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit across these key areas of responsibility.
Support management of the Upper Merion cell bank portfolio and key cell bank activities and documentation.
Maintain a strong partnership with global MSAT technical standards team to align practices and share improvements across sites.
Conduct gap analyses, propose practical corrective actions, and track closure with stakeholders.
Support internal audits, compliance checks and continuous improvement efforts.
Act as a primary contact for standards questions and support teams during changes.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in biochemical engineering, chemical engineering, biology, biochemistry or chemistry, or related technical field.
Minimum two years' post-graduate industry experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing.
Legal right to work in the United States. This role is on-site with a hybrid working pattern depending on site needs.
This role will require being on-site.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Practical knowledge of bioprocess operations such as upstream (large scale, cell banking, and/or small scale cell culture), downstream (bioseparations, purification technologies), and single-use systems.
Strong verbal and written communication skills. Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action. Effective at implementation decisions.
Strong collaboration skills and experience working with cross-functional teams. Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
Familiarity with quality frameworks and regulatory expectations relevant to bioprocessing.
Knowledge of document control systems and digital tools for standards management.
#LI-Remote
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call.
Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************
$51k-73k yearly est. Auto-Apply 8d ago
Standards Bioprocess Engineer
Gsk
Quality engineer job in King of Prussia, PA
The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle.
The MSAT standards bioprocess engineer will lead and support the creation, implementation and maintenance of technical standards for bioprocess operations for use at our Upper Merion commercial site. You will work with operators, engineers, quality and global standards teams to simplify processes and improve consistency. We value clear communication, practical problem solving and a willingness to learn. This role offers career growth, visible impact and a chance to help GSK unite science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Develop, review and maintain clear procedural and technical standards on contamination control, single-use systems, cleaning validation, lifecycle management, leachable and extractables, and cell banking.
Serve as a technical enterprise leader across the Upper Merion site, to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit across these key areas of responsibility.
Support management of the Upper Merion cell bank portfolio and key cell bank activities and documentation.
Maintain a strong partnership with global MSAT technical standards team to align practices and share improvements across sites.
Conduct gap analyses, propose practical corrective actions, and track closure with stakeholders.
Support internal audits, compliance checks and continuous improvement efforts.
Act as a primary contact for standards questions and support teams during changes.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in biochemical engineering, chemical engineering, biology, biochemistry or chemistry, or related technical field.
Minimum two years' post-graduate industry experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing.
Legal right to work in the United States. This role is on-site with a hybrid working pattern depending on site needs.
This role will require being on-site.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Practical knowledge of bioprocess operations such as upstream (large scale, cell banking, and/or small scale cell culture), downstream (bioseparations, purification technologies), and single-use systems.
Strong verbal and written communication skills. Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action. Effective at implementation decisions.
Strong collaboration skills and experience working with cross-functional teams. Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
Familiarity with quality frameworks and regulatory expectations relevant to bioprocessing.
Knowledge of document control systems and digital tools for standards management.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call.
Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************
$51k-73k yearly est. Auto-Apply 7d ago
Standards Bioprocess Engineer
GSK, Plc
Quality engineer job in King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle.
The MSAT standards bioprocess engineer will lead and support the creation, implementation and maintenance of technical standards for bioprocess operations for use at our Upper Merion commercial site. You will work with operators, engineers, quality and global standards teams to simplify processes and improve consistency. We value clear communication, practical problem solving and a willingness to learn. This role offers career growth, visible impact and a chance to help GSK unite science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
* Develop, review and maintain clear procedural and technical standards on contamination control, single-use systems, cleaning validation, lifecycle management, leachable and extractables, and cell banking.
* Serve as a technical enterprise leader across the Upper Merion site, to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit across these key areas of responsibility.
* Support management of the Upper Merion cell bank portfolio and key cell bank activities and documentation.
* Maintain a strong partnership with global MSAT technical standards team to align practices and share improvements across sites.
* Conduct gap analyses, propose practical corrective actions, and track closure with stakeholders.
* Support internal audits, compliance checks and continuous improvement efforts.
* Act as a primary contact for standards questions and support teams during changes.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor's degree in biochemical engineering, chemical engineering, biology, biochemistry or chemistry, or related technical field.
* Minimum two years' post-graduate industry experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing.
* Legal right to work in the United States. This role is on-site with a hybrid working pattern depending on site needs.
* This role will require being on-site.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Practical knowledge of bioprocess operations such as upstream (large scale, cell banking, and/or small scale cell culture), downstream (bioseparations, purification technologies), and single-use systems.
* Strong verbal and written communication skills. Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action. Effective at implementation decisions.
* Strong collaboration skills and experience working with cross-functional teams. Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
* Familiarity with quality frameworks and regulatory expectations relevant to bioprocessing.
* Knowledge of document control systems and digital tools for standards management.
#LI-Remote
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call.
Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
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$51k-73k yearly est. Auto-Apply 7d ago
Bioprocess Engineer
Integrated Project Services
Quality engineer job in Blue Bell, PA
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Bioprocess Engineer to join our team based out of any of our offices in the U.S. (MA, NJ, MD, PA, NC, KS, or CA).
In this role, you will be responsible for designing and implementing manufacturing processes and supporting utilities on a scale that can range from developmental pilot plants to full commercial production.
Additional Responsibilities
* Coordinate with project managers to determine project scope, complexity, and schedule for the project.
* Develop project execution plans (budget, milestones, deliverables, and staffing plans) to deliver the project on time, on budget, and of the highest quality.
* Assist clients in strategic evaluations to develop concepts supported by engineering studies for expanding, improving, or automating existing facilities.
* Write the scope of work for process, utilities, and manufacturing controls based on preliminary reviews with the client.
* Complete design deliverables for single unit operations through the entire facility flow, including Process Flow Diagrams (PFD), Material and Energy Balances, utility requirements, and Process P&IDs that include controls strategy and CIP/SIP functions, if appropriate.
* Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation.
* Make use of and participate in the development of company design tools, including process simulation and smart P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).
* Establish and maintain excellent working relationships with clients and members of the IPS design.
* For applicants located in Northern California, the salary offered for this role is between $117,000 and $157,000, but the actual salary offered is dependent on experience, skill set, and education.
* For applicants located in Southern California, the salary offered for this role is between $112,000 and $150,000, but the actual salary offered is dependent on experience, skill set, and education.
* For applicants located in the state of New Jersey, the salary offered for this role is between $107,000 and $143,000, but the actual salary offered is dependent on experience, skill set, and education.
Qualifications & Requirements
* Substantial process design and operations experience in pharmaceutical facilities, which should include Biologic, Vaccine, and/or ATMP products.
* Degree in natural sciences and/or engineering discipline (Biotechnology, Biology, Biochemistry, Process, Mechanical Engineering or related field).
* Knowledge of system design, applicable codes, and cGMPs as they affect process design and equipment specification.
* Knowledgeable in process simulation and creating P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).
* Possesses a demonstrated ability for analytical thinking, and an aptitude for structure.
All interviews are conducted either in person or virtually, with video required.
#LI-JP1
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
#LI-JP1
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
* Substantial process design and operations experience in pharmaceutical facilities, which should include Biologic, Vaccine, and/or ATMP products.
* Degree in natural sciences and/or engineering discipline (Biotechnology, Biology, Biochemistry, Process, Mechanical Engineering or related field).
* Knowledge of system design, applicable codes, and cGMPs as they affect process design and equipment specification.
* Knowledgeable in process simulation and creating P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).
* Possesses a demonstrated ability for analytical thinking, and an aptitude for structure.
All interviews are conducted either in person or virtually, with video required.
#LI-JP1
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Bioprocess Engineer to join our team based out of any of our offices in the U.S. (MA, NJ, MD, PA, NC, KS, or CA).
In this role, you will be responsible for designing and implementing manufacturing processes and supporting utilities on a scale that can range from developmental pilot plants to full commercial production.
Additional Responsibilities
* Coordinate with project managers to determine project scope, complexity, and schedule for the project.
* Develop project execution plans (budget, milestones, deliverables, and staffing plans) to deliver the project on time, on budget, and of the highest quality.
* Assist clients in strategic evaluations to develop concepts supported by engineering studies for expanding, improving, or automating existing facilities.
* Write the scope of work for process, utilities, and manufacturing controls based on preliminary reviews with the client.
* Complete design deliverables for single unit operations through the entire facility flow, including Process Flow Diagrams (PFD), Material and Energy Balances, utility requirements, and Process P&IDs that include controls strategy and CIP/SIP functions, if appropriate.
* Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation.
* Make use of and participate in the development of company design tools, including process simulation and smart P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).
* Establish and maintain excellent working relationships with clients and members of the IPS design.
* For applicants located in Northern California, the salary offered for this role is between $117,000 and $157,000, but the actual salary offered is dependent on experience, skill set, and education.
* For applicants located in Southern California, the salary offered for this role is between $112,000 and $150,000, but the actual salary offered is dependent on experience, skill set, and education.
* For applicants located in the state of New Jersey, the salary offered for this role is between $107,000 and $143,000, but the actual salary offered is dependent on experience, skill set, and education.
$51k-73k yearly est. Auto-Apply 60d+ ago
Process Engineer
Tata Consulting Services 4.3
Quality engineer job in Raritan, NJ
* Product formulation and launch experience. * Biomaterials and material development. * Knowledge of Medical devices and combination products; PMA familiarity. * Problem-solving using Analytical tools. * Knowledge of Design of Experiments (DOE). * Protocol development, reporting, and documentation.
* In-vitro/ex-vivo characterization of prototypes.
* Strong communication and collaboration across teams.
* Ability to work in ambiguous environments and deliver outcomes.
* Experience with self-directed teams and multitasking.
* Effective prioritization and decision-making.
* Travel up to 20% may be required (domestic and international)
Roles & Responsibilities
* Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
* Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes. Drive selection of lab scale and pilot scale equipment.
* Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
* Lead raw material suppliers through raw material iterations, correlating to product design window
* Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
* Peer review, coach and develop earlier in career engineers with respect to Process Design
Salary Range $110,000-$125,000year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
$110k-125k yearly 14d ago
Quality Technician, Wire Grind (QTWG)
KMM Group 3.7
Quality engineer job in Hatboro, PA
KMM Group offers rewarding opportunities to propel the world forward through mission critical components for air, space, life-saving equipment and more.
You don't want to miss out on this opportunity!
A few of our Company Values:
Paid to Think
Make it Fun
Choose Positive
Support Each Other
Strive for Excellence
Inspire Passion
Job requirements
Quality Technician, Wire Grind (QTWG)
📍 Hatboro, PA | Full-Time
At KMM Group, Ltd., we craft mission-critical components that fuel life-saving medical devices and cutting-edge aerospace systems. We are seeking a Quality Technician, Wire Grind (QTWG) to join our team. The QTWG requires an acute eye for detail and strong visual acuity. Though there is some aspect of dimensional measurement in the position, a greater percentage of the work is connected to the visual inspection of critical characteristics of guidewires/corewires (GW/CW)
🔧 What You'll Do
Tactical Responsibilities
a. Visual inspection of GW/CW
i. Roll test
ii. Length test
iii. PTFE damage
b. Tensile testing as required
c. Perform final dimensional inspection operations as required (if applicable)
d. Perform FAI as required (if applicable)
e. Document all findings using Good Documentation Practices (GDP)
f. Wash wires
g. Package wires
Strategic Responsibilities
Become proficient at all aspects of the visual inspection process for GW/CW in order to maximize the throughput of wires through QC
Physical Requirements and Demands:
Keen attention to detail is required for success in QC
Ability to sit at a desk, or QC work station, for prolonged periods of time
✅ What You Bring:
High School diploma or equivalent
Prefer experience in a manufacturing-based pre-apprenticeship program which offers;
i. Basic understanding of GD&T
ii. Basic understanding of use of measuring instruments
🚀 Why Join KMM Group?
Meaningful Work - Build and inspect parts that power technologies protecting and improving lives
Innovation Culture - We live our values:
Paid to Think, Make it Fun, Support Each Other, Strive for Excellence, Inspire Passion
Team-Driven Environment - Join a group of professionals who value precision, integrity, and impact
Career Growth - Expand your technical skillset and shape your career within a forward-thinking organization
🛡️Benefits & Perks Offered:
Healthcare: Medical, Prescriptions, Dental Vision Insurance
Life & Disability Insurance
Supplemental: Health Insurances (Hospital Indemnity, Critical Illness Care, etc. - Paid by Employee
Total Wellbeing Programs & Mobile Mental Health Hub
Financial Academy
Paid Holidays and PTO
401k Plan w/Employer Match
Employee Assistance Program (EAP)
Professional Development Programs, Education
Dedicated Manager of Training
Dedicated HR staff to support your needs
Benefits related Employee Advocacy Team
***All benefits listed herein are for information purposes and subject to change.
NOTE: KMM is an ITAR Registered Facility and thus anyone applying for this role must be a US Citizen or have a valid Green Card.
***Offered Compensation is commensurate with experience.
All done!
Your application has been successfully submitted!
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How much does a quality engineer earn in Bensalem, PA?
The average quality engineer in Bensalem, PA earns between $57,000 and $97,000 annually. This compares to the national average quality engineer range of $61,000 to $103,000.
Average quality engineer salary in Bensalem, PA
$75,000
What are the biggest employers of Quality Engineers in Bensalem, PA?
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