Quality Assurance Associate (cGMP Pharmaceutical)
Quality assurance analyst job in Bethlehem, PA
Quality Assurance Associate * No C2C or sponsorship available for this job.
$65-70k
Potential Contract-to-Direct for the right person!
Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Assurance Associate. In this position, you'll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide!
Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.
Essential Duties & Responsibilities
Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products.
Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control.
Manage multiple priorities while providing leadership, guidance, and feedback to team members.
Drive packaging OEE (Overall Equipment Effectiveness) initiatives.
Support qualifications, deviations, customer complaints, investigations, and systems compliance.
Maintain oversight of the PAS-X system and ensure 24/7 audit readiness.
Support regulatory audits with thorough preparation and follow-through.
Lead document control activities to ensure accuracy, consistency, and compliance.
Education & Experience
Bachelor's degree or higher in a scientific, quality assurance, or technical field.
0-2 years of experience in the pharmaceutical or related regulated industry, including compliance and project management.
Deep understanding of cGMPs, regulatory standards, and industry best practices.
Proven ability to conduct investigations, interpret regulations, and make sound quality decisions.
Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels.
Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
Strong problem-solving skills with the ability to lead projects and deliver timely results.
SAP Application Observability and Automation Lead
Quality assurance analyst job in Raritan, NJ
Must Have Technical/Functional Skills
We are seeking a highly skilled and proactive SAP Application Support Lead specializing in Observability and Automation to join our team in Raritan, NJ. This role requires a strong technical foundation in SAP systems, hands-on experience with observability tools and automation frameworks, and the ability to lead support operations with strategic insight and managerial excellence.
• Strong experience in SAP application support across modules (FI/CO, MM, SD, etc.).
• Expertise in observability tools (e.g., Dynatrace, Splunk, SAP Focused Run, Grafana).
• Hands-on experience with automation frameworks (e.g., Ansible, Python scripting, SAP Intelligent RPA).
• Knowledge of SAP BTP (Business Technology Platform) and its integration capabilities.
• Understanding of ITIL processes and incident/change management.
Roles & Responsibilities
• Lead SAP application support initiatives with a focus on observability, monitoring, and automation across landscapes.
• Design and implement observability strategies using modern tools to ensure system health, performance, and proactive issue detection.
• Drive automation of routine support tasks, incident resolution, and system checks to improve efficiency and reduce manual effort.
• Collaborate with cross-functional teams to ensure seamless integration and support of SAP modules.
• Provide leadership and mentorship to offshore and onshore support teams.
• Develop and maintain dashboards, alerts, and reporting mechanisms for SAP system performance and reliability.
• Ensure compliance with SLAs and support KPIs.
• Participate in root cause analysis and continuous improvement initiatives.
Generic Managerial Skills, If any
• Proven ability to lead and manage global support teams.
• Strong communication and stakeholder management skills.
• Experience in planning, prioritizing, and delivering support services in a high-demand environment.
• Ability to drive continuous improvement and innovation in support operations.
Salary Range: $120,000 - $140,000 a Year
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.
Automation Engineer
Quality assurance analyst job in Upper Providence, PA
One of our large Biopharmaceutical clients is seeking an Automation Engineer to join their growing team. This person will be responsible for owning a project list of scripts that have to be written for the automation of liquid handlers. We are looking for a skilled automation engineer who has experience in a biopharmaceutical setting and can fully own the script writing automation process without leadership oversight.
REQUIRED SKILLS AND EXPERIENCE
Automation Engineering Experience Tecan Fluent Software Experience Script/Method Generation In Vitro DMPK Assay and Sample Management Experience
NICE TO HAVE SKILLS AND EXPERIENCE
Tecan Fluent Training
Compensation:
$62.00/hr
Exact compensation may vary based on several factors, including skills, experience, and education.
Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k)-retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.
Quality Assurance Engineer - Medical Device Manufacturing
Quality assurance analyst job in Doylestown, PA
Job DescriptionDescription:
As a Quality Engineer you provide quality engineering support and expertise in all stages of the product life-cycle to ensure that Peregrine and DORC branded products meets specifications, issues are adequately and timely resolved, and quality of product, process and supplier quality shows continuous improvement.
Location: This position is on-site at our New Britain, PA production facility.
About the position
Ensure that protocols, reports, and records created as part of product and process development as well as changes in products and processes are critically independently reviewed for content and compliance
Drive and support continuous improvement across the organization by providing quality engineering expertise to improve robustness of design, process and supplied material
Optimize, align, and control the inspection and measurements methods (including level of inspection) and acceptance criteria across the supply chain
Support of the operations, engineering and purchasing department in case non-conforming materials are detected by owning the process of non-conforming products
Implementation of immediate mitigation actions in case non-conforming materials are detected
Coordinate and support root cause investigations
Prevent reoccurrence of quality issues
Monitoring progress in corrective action implementation
Verify that corrections and corrective actions are effective
Ensure documentation on NCs and SCARs is complete at closure
Provide periodic reporting and trending.
Ensure that suppliers used by DORC have the capabilities to meet DORC requirements and are selected, qualified, evaluated and maintained per internal procedures.
Maintain relationship with and oversight on suppliers through periodic visits and execution of supplier audits.
Drive efforts to increase the maturity of the internal organization as well as suppliers.
Requirements:
Skills, know-how and experience:
Bachelor's degree (or equivalent ability) in relevant technical field required. Master's degree preferred.
Minimum 3 years in quality engineering in a regulated environment
Knowledge of mechanical, plastics and/or electrical parts and their manufacturing methods
Understanding of quality system requirements (ISO9001, ISO13485 or similar)
Relevant experience in quality engineering in product development, production, and/or supplier management
Experience in conducting audits preferably against ISO13485 standard
Experience in participating in and/or leading quality improvement projects
Understanding of and experience with inspection and measurement methods and/or other concepts to assure quality of materials and product
Understanding of the application of statistics in quality control
Fluent English (written and spoken)
Ability to work independently in a geographically separated multi-national and multi-functional team environment
Collaborates effectively in international cross-functional teams
Communicate actively with production engineers
Open minded for improvement opportunities and change towards striving for best-in-class compliance performance
High level of integrity and ethical standards
What does Peregrine Surgical have to offer you?
Peregrine Surgical, LLC is part of the Dutch Ophthalmic Research Center - a Zeiss Company; we value our employees and provide top tier benefits. You can expect the following:
3 weeks of vacation (accrued)
10 sick days annually (prorated for new hires)
10 US holidays
90% of Health Insurance premiums paid by the company.
Dental & Vision coverage
401k plan with company match
Paid short term, long term & basic life insurance paid by the company.
Bonus program
Did you know ...?
DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities...
Will you be our new Quality Assurance Engineer?
Are you up for this? Then apply today! Do you still have questions? Then contact Monique Christy, Human Resources: ************************.
Carl Zeiss Meditec USA, Inc and its subsidiaries provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Easy ApplyEngineer III, QA
Quality assurance analyst job in Allentown, PA
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as “There is a Patient Waiting.” Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.
Discover Impactful Work:
Our company is seeking a Quality Engineer responsible for quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management (temperature, humidity, differential pressure), and oversite of Maximo work order system (calibration, corrective maintenance).This role requires the ability to make decisions that are based on sound quality/compliance principles and appropriate GMP Regulations.
A Day in the Life:
Apply Good Manufacturing Principles in all areas of responsibility.
Demonstrate and promotes the company vision.
Review impact analysis of changes to facilities and equipment.
Review and Approve GMP documents to ensure compliance with all applicable internal and regulatory standards.
Advises management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
Drives continuous improvement to the site's equipment and facilities qualification/validation program.
Ensure Compliance to the site calibration program.
Supervise the preventative maintenance program.
Facilitate, participate, and approve Risk Assessment.
Conduct all activities in a safe and efficient manner.
Other duties may be assigned to meet business/compliance needs.
Keys to Success:Education
Bachelors degree engineering or science fields is required.
Experience
4-5 years in Qualification and Validation in pharma, or medical device environment required.
A minimum of 2 years in the pharmaceutical/related regulated industry.
Experience with process validation in Quality Systems.
Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
Experience in Risk Assessment!
Knowledge, Skills, Abilities
Must be detail oriented to detect errors or deficiencies in validation and qualification documentation and requirements of the system
Utmost integrity and personal responsibility are required to maintain the for regulatory compliance.
Good written and verbal and communication skills.
Detailed understanding of regulatory documentation requirements.
Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
Ability to work independently.
Familiarity with or experience in Microsoft Word, Excel, Power Point, TrackWise, and Calibration/PM Systems.
Proficiency in skills required to read, understand, and enforce to the SOPs and policies of a GMP environment.
Physical Requirements
This position is administrative and is positioned in an office environment but does require some time in manufacturing, packaging, and computer areas.
It requires standing bending reaching, walking and talking as well as exerting up to 20lbs.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Auto-ApplyQuality Assurance Assistant (Manufacturing Plant) ~ $2,000 Sign On Bonus
Quality assurance analyst job in Quakertown, PA
Cleveland Steel Container, an Employee Owned and World Class Steel Pail Manufacturing company, is seeking an enthusiastic, responsible, and customer-oriented individual that has a positive attitude and shares the values of our company culture, which is built around teamwork, family, honest communication and producing desirable results for our Quakertown, PA manufacturing facility.
INDUSTRY LEADING BENEFIT PROGRAM THAT INCLUDES LOW EMPLOYEE PREMIUMS FOR MEDICAL INSURANCE, UNMATCHED RETIREMENT PROGRAMS AS AN EMPLOYEE OWNER. DENTAL, VISION, LIFE AND DISABILITY INSURANCES. NEW EMPLOYEES ARE ELIGIBLE FOR 15 DAYS OF PAID VACATION PER CALENDAR YEAR AND 11 PAID COMPANY HOLIDAYS.
SIGN ON BONUS OF $2,000 PAID OUT IN FIVE INSTALLMENTS OVER THE COURSE OF ONE YEAR.
$1,000 REFERRAL BONUS FOR ANYONE THAT IS REFERRED THAT GETS HIRED BY THE COMPANY
This Quality Assurance Technician position is responsible to ensure company and customer quality standards are being achieved.
Duties and Responsibilities:
Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods
Assist with incoming inspections for internal / external suppliers as directed.
Confirm discrete job special instructions are being followed or met
Member of daily audit team for various product and process audits per checklist
Participant in the revision and update of standard operating procedures.
Conduct and complete Internal Quality audits and may be involved in the development of testing methods
Ensure employees adhere to safety and quality standards
Skills and qualifications:
1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus)
High School Diploma or GED: required
ISO 9000 and 5S Program knowledge and experience
Customer focused mindset
Proven hands-on shop floor experience; forklift experience
Working knowledge Microsoft Office (Word, Excel, PowerPoint)
Good work record; Strong work ethic
Strong communication and interpersonal skills
Good teamwork and time management skills
Experience in a high volume fast paced environment
Cleveland Steel Container was founded in 1963 to provide customers with a dependable steel pail. Currently, we have four pail plants located strategically throughout the United States to support our customers. At our Streetsboro facility, we have a metal stamping plant to provide component parts for our pails. Our goal is to continuously provide our customers with quality pails through excellent service at an outstanding value. Finally, we make good pails and deliver them on time!
Cleveland Steel Container offers a competitive salary based on commensurate experience and a comprehensive benefits program that includes medical, dental, and vision insurance, flexible spending accounts, 401k with company contribution, profit sharing, paid holidays and vacations, life insurance and short & long-term disability coverages along with an Employee Stock Ownership Plan (ESOP).
TEST PA004 - Montgomery Mall General Application
Quality assurance analyst job in North Wales, PA
Christian Brothers Automotive
Our mission is simple: To create an uncommonly great experience for customers in need of auto service and repair. Christian Brothers Automotive was founded in 1982 on the principles of honesty and integrity. These principles have taken our organization to over 300+ locations all across the country. We strive for excellence in service as the #1 Automotive Repair Franchise in the country. We have a great culture, a great mission, and a great time. We hope you'll consider joining us!
The job description will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration.
Qualifications
The qualifications will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration.
Additional Information
All of your information will be kept confidential according to EEO guidelines. Christian Brothers Automotive is an Equal Opportunity Employer.
Master-Level Quality Assurance Specialist
Quality assurance analyst job in Lansdale, PA
Delivering mission-critical, electronic solutions that protect lives. Use your creativity and critical thinking to take our products from concept to customer. At CAES, we engineer solutions for the world's most critical missions. We serve customers in the defense and aerospace markets.
Seeking a career that offers challenging, diverse projects and opportunities? Looking for a position with a company that offers long-term professional advancement? Searching for a place that values a diverse, team-based environment? One that values YOU. Consider CAES.
The most important thing we build is TRUST
Overview
CAES Lansdale, PA is seeking a Master‑Level Quality Assurance Specialist to champion excellence in aerospace and defense. As a subject matter expert in data capture, analysis, and quality systems optimization, you will ensure compliance with industry standards while driving continuous improvement through advanced analytics.
Collaborating across engineering, manufacturing, and program management, you'll play a pivotal role in strengthening CAES's reputation for precision, reliability, and innovation in mission‑critical environments.
Responsibilities
* Data Capture & Analysis
* Design and implement robust systems for capturing quality-related data across production and testing processes.
* Apply statistical methods (SPC, Six Sigma, regression analysis) to identify trends, anomalies, and root causes.
* Develop dashboards and automated reporting tools for real-time quality monitoring.
* Quality Management System Expertise
* Lead audits, inspections, and compliance reviews aligned with AS9100, ISO 9001, and defense industry standards.
* Establish and maintain quality metrics (yield, defect rates, corrective actions).
* Process Improvement
* Recommend process changes that reduce variability and enhance reliability.
* Utilize audit findings to correct and implement process and procedural improvements
* Cross-Functional Collaboration
* Interface cross-functionally , with suppliers, and customers to ensure quality expectations are met.
* Present findings and recommendations to senior leadership using clear, data-backed insights.
Qualifications
Minumum:
* Education: Bachelor's Degree in Quality Assurance, Industrial Engineering, Data Analytics, or related field.
* Technical Skills:
* 5 years experience with ERP/MES systems and digital quality management tools
* 5 years of demonstrated expertise in applying AS9100, ISO 9001, and IPC standards within quality management systems
* 5 years of experience editing and indexing Command Media to ensure alignment with organizational and industry standards
* Soft Skills
* Proven analytical and problem‑solving expertise, with the ability to identify issues and implement effective solutions.
* Excellent communication skills, adept at conveying complex information clearly to both technical teams and executive stakeholders.
* Demonstrated leadership and mentoring experience, fostering collaboration, guiding team development, and driving performance.
* This position requires access to technology, materials, software or hardware that is controlled by US export laws. In order to be eligible for this position, you must be a "US Person" under US export laws (or eligible for approval under a U.S. Government export license).
* Ability to obtain and maintain a security clearance.
Preferred:
* Education: Master's Degree in Quality Assurance, Industrial Engineering, Data Analytics, or related field.
* Technical Skills:
* 8+ years experience with ERP/MES systems and digital quality management tools
* 8+ years of demonstrated expertise in applying AS9100, ISO 9001, and IPC standards within quality management systems
* 8+ years of experience editing and indexing Command Media to ensure alignment with organizational and industry standards
* Experience:
* Minimum 7-10 years in aerospace/defense QA, with at least 3 years in a senior or lead role.
Salary Range: $107,200 - $160,800 annually (Lansdale PA)
Employees may be eligible for a discretionary bonus in addition to base bay. Applicable pay within the posted range may vary based on factors including, but not limited to, geographical location, job function of the position, education, and experience of the successful candidate. Annual bonuses are designed to reward individual contributions as well business results. CAES provides a variety of benefits including health insurance coverage, life and disability insurance, 401K, paid holidays and vacation.
EMPLOYMENT TRANSPARENCY
BENEFITS
We take care of our people and provide competitive health, wealth and wellbeing benefits - from day one. You'll also discover learning and development opportunities so you can take your career to the next level - and beyond.
Other benefits include:
* Comprehensive PTO, Paid Holiday and Paid Family Leave Programs.
* Student Loan Repayment Program & Tuition Reimbursement
* 9/80 Alternate Work Week Schedule
* Tailored Management/Leadership Training
* Innovative Medical Programs, Including Family Forming
ABOUT CAES
CAES is the largest provider of analog and radiation hardened technology for the United States aerospace and defense industry. From human spaceflight and space exploration, to missile defense and electronic warfare, to healthcare solutions addressing COVID-19, our talented team develop high performing electronic solutions that work the first time, every time.
WE ARE AN EQUAL OPPORTUNITIES EMPLOYER
At CAES we welcome differences and celebrate new ideas. We believe the diversity of our people inspires our creativity and drives our innovation. Everyone is welcome here, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or genetic information.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation due to a disability for any part of the employment process, please email ********************.
Ariba Business Analyst
Quality assurance analyst job in Allentown, PA
360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement.
Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile.
Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us.
We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change.
Job Description
Functional Business Analyst
ARIBA P2P, SIM and APC Experience
Local Required
Additional Information
Unfeigned Regards,
Preeti Nahar | SR.Talent & Client Acquisition Specialist | 360 IT Professionals Inc.
C: +1 510-254-3300 ext. 140
Quality Assurance Specialist - Allentown PA
Quality assurance analyst job in Allentown, PA
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Let's do this! Let's change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.
Responsibilities:
Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
Review documentation associated with receipt, storage, and distribution
Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership, guidance, mentorship, and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives, programs, and projects targeting operational improvements
Develop solutions that are comprehensive, practical, and align with functional goals
Perform additional duties as assigned by management
Additional Qualifications/Responsibilities
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master's degree and 2 years of quality assurance experience OR
Bachelor's degree and 4 years of quality assurance experience OR
Associate's degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications:
Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
Expertise in managing deviations, change controls, and CAPAs
Proficiency in Veeva, SM LIMS, and ERP systems
Knowledge of industry standards (GMP, GDP, Import/Export)
Commitment to exemplifying Amgen's core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel, Word, and PowerPoint
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Quality Assurance Assistant
Quality assurance analyst job in Allentown, PA
DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities:
Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods
Assist with incoming inspections for internal / external suppliers as directed
Confirm discrete job special instructions are being followed or met
Member of daily audit team for various product and process audits per checklist
Participant in the revision and update of standard operating procedures
Conduct and complete Internal Quality audits and may be involved in the development of testing method
Ensure employees adhere to safety and quality standards
Skills and qualifications:
1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus)
High School Diploma or GED: required
ISO 9000 and 5S Program knowledge and experience
Measuring tools knowledge and experience
Customer focused mindset
Proven hands-on shop floor experience; forklift experience
Working knowledge Microsoft Office (Word, Excel, PowerPoint)
Good work record; Strong work ethic
Strong communication and interpersonal skills
Good teamwork and time management skills
Experience in a high volume fast paced environment
Once you apply, please text "QAA" to ************ for a faster reply.
INDH
Auto-ApplyQA Clinical Supplies Specialist
Quality assurance analyst job in Lansdale, PA
Piper Companies is seeking a QA Clinical Supplies Specialist to join a major pharmaceutical manufacturing company located in Lansdale, PA. This is a Hybrid role. The QA Clinical Supplies Specialist will ensure the quality, compliance and integrity of clinical trial supplies.
Responsibilities of the QA Clinical Supplies Specialist include:
* Ensure clinical supply materials meet company policies and regulatory standards.
* Lead projects aimed at improving process performance, including yield improvement, cost reduction, and cycle time reduction.
* Assist in coordinating significant quality events, including fact-finding and investigation support.
Qualifications for the QA Clinical Supplies Specialist include:
* At least 2 years of experience in the Pharmaceutical or a related industry, specifically in a Good Manufacturing Practice (GMP) field such as Technical, Engineering, Quality, or Operations
* Familiarity with batch disposition activities and Good Manufacturing Practices (GMP).
* Excellent problem-solving, communication, and collaboration skills.
* Basic understanding of Microsoft applications (Excel, Outlook, Access) and knowledge of ERP/MES, Trackwise, and SAP systems.
* Bachelor's degree in a related field.
Compensation for the QA Clinical Supplies Specialist include:
* Salary Range: $40-45/hr.
* Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave if required by law, and Holidays
This job opens for applications on 3/21/2025. Applications for this job will be accepted for at least 30 days from the posting date.
* Keywords: Quality Assurance, QA, pharma, problem-solving, GMP, good manufacturing practices, collaboration, batch disposition, operations, regulatory standards, projects, clinical, Process Improvement, analytical testing, training and development, change control, quality management systems, validation and qualification, documentation, risk assessment, inspection, batch records, quality control
#LI-KT1 #LI-HYBRID
ICQA Associate
Quality assurance analyst job in Bethlehem, PA
Title: ICQA Associate Hours/Shift: 1st Shift Mon - Fri 8:00 am - 4:30 pm at $20.25hr or 2nd Shift Sat - Wed 3:00pm to 11:30pm at $21.25hr If you're looking to be at the forefront of disrupting the ecommerce industry, wanting to make your mark and be continuously challenged to grow, your time has come.
ShipBob is recognized as #1 on Crain's 2020 "Fast 50" list of the fastest-growing companies in Chicago & Inc.5000 top 500 companies with the most proven track records. With this growth, we are looking for top talent to help us reach the next level.
Role Description:
This is an incredibly important position that helps to monitor inventory activities of all clients at each fulfillment center while allowing all existing operations team members to remain focused on their day-to-day responsibilities. As ShipBob continues to grow, it is imperative to provide a great experience in serving our clients' needs while maintaining sustainable growth and scalability from an operations perspective.
About Us:
ShipBob is a cloud based logistics platform that partners with over 5,200+ e-commerce businesses to help them be more successful online. We offer a full suite of fulfillment solutions for our merchants, including the ability to improve their transit times, shipping costs and deliver best in class experience to their customers. With almost 100% accuracy rate in fulfilling orders and orders shipped on time, our merchants can count on us to deliver excellent service.
ShipBob's growing fulfillment network is powered by our proprietary technology and acts as a back office for logistics, providing merchants with full visibility into orders, inventory levels in real time, and access to advanced analytics, over 27 integrations and data reporting.
As one of the fastest growing tech companies in Chicago with over $330M+ raised from blue-chip investors like Menlo Ventures, Bain Capital Ventures, Hyde Park Venture Partners and SoftBank Vision Fund 2, our goal is to continue to be the #1 best fulfillment technology in the industry. To help us meet this standard, we are scaling our entire team and looking for people who share our core values and have an entrepreneurial mindset
About You:
At ShipBob, we're looking for individuals who embody our core values:
* Be Mission-Driven. We want team members that are passionate about helping entrepreneurs improve their business, and bring that passion every day.
* Be Humble. We have ambitious goals, and our team members understand that success or failure depends on us working together and leaving egos at the door.
* Be Resilient. Logistics is a complicated business. So is software. We value team members that never give up and keep iterating until a problem is solved.
* Be a Creative Problem Solver. As a startup, we value smart, innovative solutions to complex problems. We fall in love with the problem, not our "favorite" solution.
* Be Safety Minded. It's not just talk; it's the way you work.
What You'll Do:
* Investigate inventory discrepancies reported by the Operations team.
* Perform physical inventory cycle counts, and reconcile inventory variances.
* Communicate updates and relay important operational information about clients directly to ICQA Lead.
* Play a pivotal role in understanding the root cause of inventory adjustments and participate in efforts to correct.
* Vocalize concerns around inventory practices to ICQA Lead, helping to identify areas of opportunity in day to day processes.
Expectations:
* Proficient in cycle counting and inventory control processes according to written SOP's.
* Perform Root Cause Analysis around inventory discrepancies and review findings with ICQA Lead.
* Ensure inventory variances are researched and resolved in a timely manner, allowing fulfillment of outbound orders.
* Ensure timely communications to MC team for any orders not able to be fulfilled due inventory discrepancies.
What You'll Bring To The Table:
* Demonstrates the ability to quickly adapt to changing conditions and solve problems immediately.
* Ability to determine inventory discrepancies, perform physical inventory cycle counts, and reconcile inventory variances.
* Possesses effective written and verbal communication skills; displays reading comprehension skills.
* Displays the ability to multitask and handle multiple issues at the same time without stress.
* Displays attention to details.
* Ability to lift 40lbs without any health limitations.
* Able to stand and walk continuously during and up to an 8-10hr shift.
* Able to bend, stoop, reach above, and push/pull frequently.
* May be required to flex into other departments for support as needed.
We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions.
Perks and Benefits:
* Medical, Dental, Vision & Basic Life Insurance
* 401K Match
* Variety of voluntary benefits, such as: short term disability
* Weekly paychecks & Wage Progression Program
* KinderBob Daycare Stipend program
* Paid Time Off & Sick Time Off
* Referral Bonus Program
* Fun Culture >>> Check us out on Instagram
Reports to: ICQA Area Manager
Classification: Hourly/Non-Exempt
ShipBob provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Quality Assurance Specialist II
Quality assurance analyst job in Raritan, NJ
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Specialist II! This position will be located in Raritan, NJ!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at *************** and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
In this role, you will be providing quality oversight for daily activities related to the production of viral vectors in a controlled cGMP environment. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
Main Responsibilities will include, but are not limited to:
Partner with Operations teams to support production activities in a cGMP manufacturing facility.
Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation.
Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Author and revise Quality departmental documents.
Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
Participate in continuous improvement activities.
Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.
Other duties may be assigned as necessary.
Qualifications
Education:
A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.
Skills & Experience:
Required:
Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance
Ability to be organized and capable of working in a team environment with a positive demeanor.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Ability to work independently on routine tasks.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred:
Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.
Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred.
Other:
Requires ability and flexibility to work 8-hour shifts 1st shift Monday - Friday, and provide occasional off shift or weekend support, as needed.
This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#CAR-T
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$69,500-$102,350 USD$
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplyQA Change Control Specialist II
Quality assurance analyst job in Raritan, NJ
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team based in Raritan, NJ.
Role Overview
The QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities throughout the lifecycle.
Key Responsibilities
Support and streamline the site change control process.
Participate in change control process from initiation through completion.
Schedule and participate in the site change control review board meetings.
Manage change control metrics reporting.
Collaborate with functional departments to resolve issues.
Support drafting of standard operating procedures.
Support cross-functional projects with many stakeholders.
Participate in the training program for new members.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Review change controls, SOPs, and other documentation.
Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
Drive continuous improvement.
Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.
Requirements
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
Minimum of 2 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
Operational experience with electronic quality systems.
Familiarity with core Quality Management System processes.
Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus.
Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Effective interpersonal skills with the ability to communicate across all levels of the organization.
Ability to work independently with a high degree of accountability.
Proficient knowledge of Microsoft Office.
Experience in quality metrics reporting, analysis and process improvement techniques is a plus.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
#Li-BZ1
#Li-Onsite
The anticipated base pay range is$75,972-$99,713 USD
Benefits
We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug-free workplace.
Auto-ApplyQuality Assurance Specialist
Quality assurance analyst job in Allentown, PA
Career CategoryQualityJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Specialist Quality Assurance
Location
Easton, Pennsylvania - ON-SITE
What you will do
Let's do this! Let's change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.
Responsibilities:
Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
Review documentation associated with receipt, storage, and distribution
Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership, guidance, mentorship, and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives, programs, and projects targeting operational improvements
Develop solutions that are comprehensive, practical, and align with functional goals
Perform additional duties as assigned by management
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master's degree and 2 years of quality assurance experience OR
Bachelor's degree and 4 years of quality assurance experience OR
Associate's degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications:
Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
Expertise in managing deviations, change controls, and CAPAs
Proficiency in Veeva, SM LIMS, and ERP systems
Knowledge of industry standards (GMP, GDP, Import/Export)
Commitment to exemplifying Amgen's core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel, Word, and PowerPoint
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Salary Range
109,307.00 USD - 129,509.00 USD
Auto-ApplySpecialist: Quality Assurance and Training - Patient Access
Quality assurance analyst job in Montgomery, PA
Job Details
Primary Function: Assist in facilitating the work of Quality Assurance, review and improve accuracy of Front End Revenue Cycle which includes front end billing edits, front end denials, zero accounts and any other front end related revenue opportunity.
Participate in and coordinate the implementation of strategies and processes.
Participation and coordination of creation of payor update guides.
Participate and create training manuals.
Provide training and mentoring to new registrars on all shifts and current registrars in front end denial and edit findings.
Identify and report ongoing issues and possible resolutions.
Provide statistics to management.
Responsible for presenting standard training programs, prepares course materials, establishes lesson plans and administers qualifying tests.
Provides office support for all computer applications, office procedures and protocols.
Run detailed statistics to determine what areas need improvement, where denials are happening, determine how to correct processes to prevent, bring information to denial meetings.
Work with internal and external customers.
Job Description
Education/Training/Experience:
BA or BS in related field preferred OR 3-5 years in Patient Access and/or Patient Accounting Experience.
Strong verbal and written communication skills required.
1-3 years lead or supervisory experience preferred.
Patient Registration, third party billing, precertification, insurance verification experience required.
Working knowledge of registration and billing regulatory requirements including EMTALA.
Ability to prioritize tasks.
Excellent PC literacy skills required. Candidate must have a positive and strong work ethic.
EPIC AND CERNER EXPERIENCE STRONGLY PREFERRED
Work Shift
Rotating (United States of America)
Worker Sub Type
Regular
Employee Entity
Albert Einstein Medical Center
Primary Location Address
559 W. Germantown Pike, East Norriton, Pennsylvania, United States of America
Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
Benefits
Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
For more benefits information, please click here
Auto-ApplyQuality Assurance Associate
Quality assurance analyst job in Shoemakersville, PA
Meet REVOLVE:
REVOLVE is the next-generation fashion retailer for Millennial and Generation Z consumers. As a trusted, premium lifestyle brand, and a go-to online source for discovery and inspiration, we deliver an engaging customer experience from a vast yet curated offering totaling over 45,000 apparel, footwear, accessories and beauty styles. Our dynamic platform connects a deeply engaged community of millions of consumers, thousands of global fashion influencers, and more than 500 emerging, established and owned brands. Through 16 years of continued investment in technology, data analytics, and innovative marketing and merchandising strategies, we have built a powerful platform and brand that we believe is connecting with the next generation of consumers and is redefining fashion retail for the 21st century. For more information please visit ****************
At REVOLVE the most successful team members have a thirst and the creativity to make this the top e-commerce brand in the world. With a team of 1,000+ based out of Cerritos, California we are a dynamic bunch that are motivated by getting the company to the next level. It's our goal to hire high-energy, diverse, bright, creative, and flexible individuals who thrive in a fast-paced work environment. In return, we promise to keep REVOLVE a company where inspired people will always thrive.
To take a behind the scenes look at the REVOLVE “corporate” lifestyle check out our Instagram @REVOLVEcareers or #lifeatrevolve.
Are you ready to set the standard for Premium apparel?
Main purpose of the Quality Assurance Associate role:
Minimize monetary loss of defective merchandise by identifying the most effective defect recovery process for each item.
Major Responsibilities:
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Minimize monetary loss of defective merchandise including apparel, shoes, accessories and beauty
Identify the most effective defect recovery process for each item - RA, Restore, Sellable Defect, Other
Identify defects by inspecting defective merchandise of apparel and non-apparel items
Clearly communicate with vendors regarding defective and unacceptable merchandise
Aggressively negotiate credit or replacement merchandise for defects with vendors
Establish and maintain rapport with vendors through positive and consistent communications
Assist in other areas in department as needed
Required Competencies:
To perform the job successfully, an individual should demonstrate the following competencies:
High level of attention to detail and the ability to identify apparel and non-apparel flaws
Hands-on approach at restoring merchandise quickly and efficiently
Apparel construction and fabrication knowledge
Strong communications, prioritizing, and organizational skills
Ability to take ownership of assigned tasks and meet responsibilities without supervision
Ability to work successfully with any personality type and be a team player
Sense of urgency and ability to maintain performance quality under pressure
Minimum Qualifications:
Experience working in a QA/QC, Production or Warehouse environment required
Computer literate in Excel, Word and Email required
Proficient in English
Technical fashion, garment construction or fabrication knowledge preferred
Physically capable to stand and walk for entirety of shift
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to extreme cold and extreme heat.
The noise level in the work environment is usually moderate.
ATTENTION:
After submitting your application, please check your spam folder for emails on your application status. Emails are sent from an ADP email address.
The following job description contains representative examples of work that will be performed in positions allocated to this classification. It is not required that any position perform all of the duties listed, so long as primary responsibilities are consistent with the work as described. Roles and responsibilities can often be expanded to accommodate changing business conditions and goals, as well as to tap into the skills and talents of the individuals in the company. Accordingly, associates may be asked to perform duties that are outside the specific functions that are listed.
Auto-ApplyQuality Assurance Assistant
Quality assurance analyst job in Quakertown, PA
DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities:
Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods
Assist with incoming inspections for internal / external suppliers as directed
Confirm discrete job special instructions are being followed or met
Member of daily audit team for various product and process audits per checklist
Participant in the revision and update of standard operating procedures
Conduct and complete Internal Quality audits and may be involved in the development of testing method
Ensure employees adhere to safety and quality standards
Skills and qualifications:
1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus)
High School Diploma or GED: required
ISO 9000 and 5S Program knowledge and experience
Measuring tools knowledge and experience
Customer focused mindset
Proven hands-on shop floor experience; forklift experience
Working knowledge Microsoft Office (Word, Excel, PowerPoint)
Good work record; Strong work ethic
Strong communication and interpersonal skills
Good teamwork and time management skills
Experience in a high volume fast paced environment
Once you apply, please text "QAA" to ************ for a faster reply.
INDH
Auto-ApplyQA Shop Floor Specialist II/III
Quality assurance analyst job in Raritan, NJ
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey.
Role Overview
The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.
Schedule: Wed-Sat, 1
st
Shift
Key Responsibilities
Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
Support manufacturing activities for cGMP compliance through spot checks/internal audits.
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
Review of all documentation, in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs)
Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
Support batch review & material release in SAP for In-house reagents.
Support Floor Spot-check, audit trail review.
Strive to reduce non-conformances in supported areas by proactively driving compliance.
Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
Utilize multiple electronic quality systems, batch records and SAP.
Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
Provide QA shop floor support for extended periods of time.
Responsibilities will include but not limited to tasks mentioned above.
Support regulatory inspections and audits as needed.
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
Other duties will be assigned, as the need arises.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses
Color Perception both eyes 5 slides out of 8.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning
Requirements
Bachelors degree required in Life Sciences or Engineering.
0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
Experience with quality support in clinical manufacture is preferred.
Flexible to work on weekends, as needed.
Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
Is frequently required to communicate with coworkers.
While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
Ability to lift 20 lbs.
Report to work on-time.
Duties are required to be performed on-site at manufacturing facility.
Perform other duties as assigned.
Attend departmental and other scheduled meetings.
Practice good interpersonal and communication skills.
Demonstrate positive team-oriented approach in the daily execution of procedures.
Promote and work within a team environment.
Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
Support and contributes to projects.
Assist in troubleshooting issues related to manufacturing.
Technical knowledge within functional units
Demonstrate an understanding of the process in order to properly perform the assigned tasks.
Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
Utilizes tools within MS Office and other systems to improve business effectiveness.
Read and interpret documents such as safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret a variety of instructions furnished in written, oral, or diagram.
Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals,
Aseptic processing in ISO 5 clean room and biosafety cabinets.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
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The anticipated base pay range is$75,972-$99,713 USD
Benefits
We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug-free workplace.
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