Global Gap Guidelines Jobs in Usa

Job Title : Industrial Manufacturing Engineer

Customer : Pierce Manufacturing Inc.

Location : Appleton, WI 54914, United States

Visa Requirement : US Citizens / Green Card holders only

Key Skills Required

• Mandatory shop floor experience
• Time Study
• Line Balancing
• Continuous Improvement
• Value Stream Mapping (VSM)
• Lean Manufacturing

Job Description & Skill Requirements

• Study assembly lines and manufacturing processes to identify improvement opportunities based on Lean principles.
• Perform detailed time studies and line balancing activities, including:
• Elemental breakdown
• Video-based time studies
• Analysis across all processes, stations, and operators
• VA / NVA / RNVA analysis
• Development of current-state line balancing
• Muri (overburden) analysis
• Develop Value Stream Maps (VSM), including:
• Current-state VSM to identify bottlenecks, waste, and inefficiencies
• Capacity analysis and baseline performance metrics
• Future-state VSM and gap analysis between current and future states
• Identify process and productivity improvement opportunities across the entire value stream and provide:
• Level 1, 2, and 3 improvement recommendations
• Detailed improvement roadmap and reports
• Develop and revise standard work instructions, including video-based work instructions.
• Conduct root cause analysis for quality issues, defects, and downtime; support corrective actions and Kaizen initiatives with detailed implementation plans.
• Support fixture design activities as per manufacturing and process requirements.

Title: Drug Production Specialist

Location: Berkeley, CA

Duration: 1 year contract to hire

Required Skills & Experience

• 1-2 years of experience in pharmaceutical manufacturing
• Strong understanding of GMP compliance and experience working in a GMP facility

Job Description

We are seeking a highly motivated Drug Product Specialist to join our Cell Therapy Manufacturing team. This role is critical in supporting aseptic operations and ensuring compliance with GMP standards for drug product filling and related processes. The ideal candidate will have hands-on experience in aseptic techniques, drug product handling, and GMP environments.

Perform environmental monitoring in classified areas

Prepare solutions and manage inventory for manufacturing operations

Support aseptic processes including drug product filling and visual inspection

Maintain and complete electronic batch records accurately

Participate in gowning qualification, aseptic training, and media fill exercises

Assist in routine operations and troubleshooting within GMP guidelines

Collaborate with cross-functional teams to ensure smooth production flow

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Title: Data Migration Specialist

Location: San Diego, CA

Duration: 6-9 Month Assignment + Potential Extensions

Work Model: Fully On-Site

Pay rate: $21-23/hour

Start Date: March 16, 2026

JOB DESCRIPTION

One of our large CDMO clients is seeking data migration specialist to transition from a legacy Quality Management System (QMS) to MasterControl. This role focuses on extracting structured and unstructured data from the previous QMS platform, validating its accuracy, and entering and organizing information within MasterControl according to established procedures. The ideal candidate is detail‑oriented, highly organized, and comfortable working with quality documentation and regulated data environments.

Key Responsibilities

• Extract data from the legacy QMS, including documents, records, metadata, and historical logs.
• Review, clean, and validate extracted data to ensure accuracy, completeness, and compliance with internal standards.
• Input and upload data into MasterControl following defined workflows and naming conventions.
• Collaborate with Quality, IT, and Compliance teams to resolve discrepancies and clarify data requirements.
• Maintain detailed logs and status reports to track progress and identify issues during migration.
• Support testing and verification activities to ensure data integrity after import into MasterControl.
• Follow all SOPs, work instructions, and regulatory guidelines related to data handling and documentation control.

Required Skills and Experience:

• High School Diploma
• Experience with Data Entry or Document Control in a regulated environment
• Ability to type 40+ words per minute
• Microsoft Office proficiency

Nice to Have Skills & Experience:

• Experience with MasterControl

Compensation:

$21.00/hr to $23.00/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.

Position Summary

The Senior Quality Assurance Specialist is responsible for the review, approval, and compliance oversight of GMP documentation supporting manufacturing operations and process validation activities. This role partners closely with Manufacturing Sciences & Technology (MS&T) and Manufacturing teams to ensure timely batch record, BOM, and technical document approvals while maintaining compliance with U.S. and EU cGMP regulations.

Key Responsibilities

• Review and approve GMP documentation supporting manufacturing operations, including Master Batch Records, Solution Records, Equipment Preparation Records, Process Assembly Records, Test Sampling Plans, and other manufacturing records as required.
• Collaborate with MS&T and Manufacturing to support BOM review, approval, and release within ASCTrac and SAP systems to ensure production timelines are met.
• Review and approve technical documents associated with process validation and manufacturing operations, including but not limited to:
• Process Characterization
• Process Performance Qualification (PPQ)
• Resin and Membrane Qualifications
• Non-routine Sample Plans
• Provide general QA support to manufacturing operations, including participation in deviation investigations, CAPA development, procedure reviews, and change control assessments, as required.
• Perform compliance review of executed batch records and internal support records to ensure adherence to cGMP and internal quality standards.
• Attend relevant project and operational meetings.
• Support client audits, client meetings, regulatory inspections, and process improvement initiatives as needed.

Qualifications:

• Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of experience, in a QA role within a cGMP-regulated biopharmaceutical (or equivalent) environment.
• Demonstrated experience supporting Manufacturing Process Operations and validation activities in a QA capacity.
• Strong knowledge of U.S. and EU cGMP regulations and guidelines.
• Working knowledge of electronic quality management systems and manufacturing execution systems.
• Working knowledge of electronical management systems
• Familiarity with Operational Excellence principles.

The Calibration Technician is responsible for performing routine and non-routine calibration of instruments and equipment used at the Client's facility. This role ensures that all critical systems operate within specified tolerances and comply with regulatory standards, including FDA, EU, GMP, and ISO guidelines.

Essential Duties and Responsibilities:

· Perform scheduled and unscheduled calibrations on a wide range of instruments, including pressure gauges, temperature sensors, balances, pH meters, and cleanroom monitoring devices, among others, and document properly in the CMMS.

· Maintain accurate and complete calibration records in compliance with cGMP and internal quality standards.

· Troubleshoot and resolve calibration issues, including out-of-tolerance (OOT) conditions, and escalate as necessary.

· Support investigations, deviations, CAPA, and change control processes related to calibration activities.

· Ensure calibration standards and reference instruments are maintained and traceable to national/international standards.

· Assist in the preparation for internal and external audits by providing calibration documentation and technical support.

· Collaborate with Quality Assurance, Maintenance, and Production teams to ensure equipment readiness and compliance.

· Follow and contribute to the development and revision of Standard Operating Procedures (SOPs) related to calibration.

· Maintain calibration schedules and ensure timely execution to prevent overdue equipment.

· Adhere to all safety, environmental, and contamination control procedures in sterile and cleanroom environments.

· Assist with calibration SOP revisions.

· Work with data acquisition and validation equipment (e.g., process control equipment/controllers, Dataloggers, DC Analog/Signal Conditioners, and transducers).

· Troubleshoot, inspect, and repair test and measurement equipment in support of new projects.

· Provide on-site calibration support for equipment that is either too sensitive to move or is too large and not feasible to relocate.

· Work overtime when necessary to support high-priority requests or meet project goals.

· Perform preventative maintenance tasks related to calibration activities.

· Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.

· Able to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high-pressure liquids and gases, steam, and moving machinery.

· Able to check, respond to, and troubleshoot Equipment Monitoring System (EMS) & Building Management Systems (BMS) issues and alarms.

Basic Qualifications and Capabilities:

· Associate's degree or technical certification in Instrumentation, Electronics, Engineering Technology, or related field.

· Minimum of 2+ years of calibration experience in a GMP-regulated pharmaceutical or biotech environment.

· Understanding of calibration principles, metrology, and regulatory compliance (FDA, EU GMP, ISO 17025).

· Excellent documentation and communication skills.

· Proficiency with calibration management systems (e.g., CMMS, Blue Mountain, Maximo)

· Ability & experience reading schematics, wiring diagrams & other technical documents.

Preferred Qualifications:

· Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.

· Experience with regulatory inspections.

· Experience with continuous improvement/lean tools such as Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.

Our large pharmaceutical client in Spring House, PA is seeking an Associate Scientist to join their growing Cell Therapy Drug Product Development organization and support ongoing CAR-T programs. Training is provided for this role and this team provides a lot of opportunity for growth! Other responsibilities include:

• Supporting CAR-T formulation and cryopreservation activities
• Collecting, verifying and analyzing data and results
• Participating in the executive of formulation and process characterization studies
• Implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety& compliance guidelines
• Tracking and coordinating inventory and overseeing sample coordination internally
• Coordinating and storing project-specific inventory, including patient material that was procured by and for a specific team.

Qualifications:

• Minimum of 1 year of experience with cell culture and aseptic techniques
• Cell cryopreservation experience including formulation, freezing, and transfer to storage
• Bachelor's Degree or above in Biology, Biochemistry or related discipline
• CAR T Cell Therapy experience is preferred

Salary: $75,000-$85,000 (flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO: 10 PTO days, 6 paid sick days annually & paid Holidays

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Director of Patient Financial Services (PFS)

Hybrid Role – 3 Days Remote / 2 Days On‑Site Across Two Facilities

Position Overview

The Director of Patient Financial Services (PFS) provides strategic and operational leadership for all revenue cycle functions related to Accounts Receivable (AR) management, billing, and customer service across two facilities. This role oversees approximately 60 team members, including AR billing supervisors, customer service leaders, and frontline staff. The Director ensures high‑quality performance, compliance, and financial outcomes within an Epic‑based environment while fostering a culture of accountability, service excellence, and continuous improvement.

Key Responsibilities

Leadership & Strategy

• Provide vision, direction, and hands‑on leadership for AR billing, customer service, and related PFS operations across two locations.
• Lead, mentor, and develop a team of ~60 employees, including supervisors and team leads.
• Establish performance standards, KPIs, and operational goals aligned with organizational revenue cycle strategy.
• Drive a culture of collaboration, transparency, and service excellence.

Operational Management

• Oversee end‑to‑end AR workflows, including billing, follow‑up, denials, appeals, and customer service interactions.
• Ensure timely, accurate, and compliant billing practices in accordance with federal, state, and payer regulations.
• Monitor AR aging, cash collections, denial trends, and customer service metrics; implement corrective action plans as needed.
• Partner with IT and Epic analysts to optimize system workflows, templates, and reporting tools.

Cross‑Functional Collaboration

• Work closely with clinical, financial, and administrative leaders to resolve revenue cycle barriers and improve patient experience.
• Serve as a key liaison between PFS, Compliance, Finance, and Patient Access teams.
• Participate in organizational committees and initiatives related to revenue integrity and operational excellence.

Process Improvement & Compliance

• Identify opportunities to streamline processes, reduce waste, and enhance productivity.
• Ensure adherence to all regulatory requirements, payer guidelines, and internal policies.
• Lead or support audits, root‑cause analyses, and corrective action initiatives.

Qualifications

• Bachelor’s degree in Business, Healthcare Administration, Finance, or related field (Master’s preferred).
• 7+ years of progressive revenue cycle or PFS leadership experience, including multi‑site or large‑team oversight.
• Strong expertise in AR management, billing operations, and customer service within a healthcare setting.
• Demonstrated experience working in an Epic environment; certification or proficiency strongly preferred.
• Proven ability to lead large teams, manage change, and drive measurable performance improvements.
• Excellent communication, analytical, and problem‑solving skills.

Work Environment

• Hybrid schedule: 3 days work‑from‑home, 2 days on‑site across two facilities.
• Occasional travel between facilities required.
• Fast‑paced, metrics‑driven environment with high expectations for accuracy, service, and accountability.

Embark on a Journey That Makes a Difference.

At Generali Global Assistance (GGA), every day is an opportunity to help people explore the world with confidence. We’re not just in the business of protection—we’re in the business of adventure and peace of mind. Whether it’s a backpacker trekking through the Andes, a family cruising the Mediterranean, or a solo traveler chasing the Northern Lights, we’re there to ensure their journey is safe and supported. From assisting with emergency medical claims to guiding customers through trip disruptions or ID theft, your work helps turn travel challenges into stories of resilience.

Set Sail on a Career Path to Success.

Our teams value curiosity and collaboration while priding ourselves on fostering a welcoming and inclusive atmosphere for our employees. Elevate your journey through our internal programs, including:

• Diversity, Equity, and Inclusion (DEI) Committee
• Career pathing and Individual Development Plans
• Internal training and intern opportunities
• Women in Business Mentorship Program
• Employee awards and recognition
• Education and professional development assistance program

Passport to Perks Includes:

• Generous Employer contribution for health, dental, and vision insurance
• Paid Maternity and Paternity Leave
• Scholarship Program for Employee Dependents
• Company match on 401k
• Employee Assistance Program (EAP)
• Company paid short-term and long-term disability insurance
• Company paid life insurance
• Voluntary Pet Insurance
• Voluntary Legal Benefit
• Discounts on travel insurance
• Time off policies including vacation days, sick days, personal days, holidays and volunteer days (VTO)

Your Role on the Expedition:

Assists in the clerical support functions for the Liability Claims Department. Reports directly to the VP, Claims.

Chart Your Course:

• Run loss reports for Generali US Branch insureds.
• Set up new claims in the system, including entering all data and establishing reserves.
• Files claims documents and correspondence.
• Close claim files and issue claim payments.
• Process recoveries.
• Complete OFAC checks, including wires and manual checks, and maintain the processing log.
• Provide OFAC confirmations or flagged results to Compliance.
• Set up new claims when new losses are submitted.
• Obtain copies of checks and upload them to GUSB claim files.
• Distribute incoming mail.
• Maintain filing systems.
• Retrieve files and coordinate transfer to storage.
• Process wire requests for Metropolitan Reporting.
• Prepare monthly reporting for clients.
• Draft and distribute minutes from monthly meetings.
• Conduct monthly reviews of KPIs.
• Handles special out going UPS/ Register and Certified mail.
• Sorts outgoing letters and attachments and send via mail or fax.

Your Ticket to Success:

Required Qualifications:

• High School Diploma or Equivalent (GED) required.
• Communicates clearly and persuasively in both positive and challenging situations; actively listens and seeks clarification when needed.
• Proficient in PowerPoint.
• Responds effectively to questions.
• Demonstrates strong group presentation skills.
• Balances individual responsibilities with team objectives.
• Shows objectivity and openness to different perspectives.
• Reads and interprets written information effectively.
• Treats others with respect, honors commitments, and builds trust.
• Demonstrates integrity and upholds organizational values.

Preferred Qualifications:

Position Coordinates:

This is an onsite role based out of our New York City office in the Lower Manhattan - Financial District.

Pay Range: 26-31.00/hr

Time for Take-off:

While there is some flexibility in the hours, this position will be Monday-Friday during regular business hours (approximately 8:00am-5:00pm). Occasional overtime may be required according to business need.

One team. Every destination.

Generali Global Assistance is proudly part of the Europ Assistance Group and our products utilize a number of corporate and product brands. The brands for our North American team include the following:

• CSA: US travel insurance brand for retail, tour operator, cruise and lodging partners. Learn more here.
• Generali Global Assistance (GGA): The primary Corporate brand in the United States for our travel insurance, travel assistance, identity and cyber protection, and beneficiary companion products. Learn more here.
• GMMI: the industry standard for global medical cost containment and medical risk management solutions. Learn more here.
• Iris, Powered by Generali: identity and digital protection solution. Learn more here.

Explore new horizons – apply today!

Don’t meet every single requirement? At Generali Global Assistance, we are dedicated to building a diverse, inclusive and enriching workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

California Residents - Privacy Notice for California Residents Seeking Employment with Generali Global Assistance is available here: Company is committed to providing equal employment opportunity in all our employment programs and decisions. Discrimination in employment on the basis of any classification protected under federal, state, or local law is a violation of our policy. Equal employment opportunity is provided to all employees and applicants for employment without regard age, race, color, religion, creed, sex, gender identity, gender expression, transgender status, pregnancy, childbirth, medical conditions related to pregnancy or childbirth, sexual orientation, national origin, ancestry, ethnicity, citizenship, genetic information, marital status, military status, HIV/AIDS status, mental or physical disability, use of a guide or support animal because of blindness, deafness, or physical handicap, or any other legally protected basis under applicable federal, state, or local law. This policy applies to all terms and conditions of employment, including, but not limited to, recruitment and hiring, classification, placement, promotion, termination, reductions in force, recall, transfer, leaves of absences, compensation, and training. Any employees with questions or concerns about equal employment opportunities in the workplace are encouraged to bring these issues to the attention of Human Resources. The Company will not allow any form of retaliation against individuals who raise issues of equal employment opportunity. All Company employees are responsible for complying with the Company’s Equal Opportunity Policy. Every employee is to treat all other employees equally and fairly. Violations of this policy may subject an employee to disciplinary action, up to and including termination of employment.

Job Title: Emissions Certification Engineer

Location: Dearborn, MI

Role Overview:

We are seeking an experienced Emissions Certification Engineer to support regulatory certification and compliance activities for gasoline, diesel, and hybrid powertrain programs. The candidate will work closely with calibration, testing, and regulatory teams to ensure vehicles meet EPA and CARB emissions standards.

Key Responsibilities:

• Lead vehicle and engine emissions certification submissions to EPA & CARB
• Prepare and manage certification documentation per CFR requirements
• Coordinate emission testing (FTP-75, US06, HWFET, WLTP, etc.)
• Support powertrain calibration teams to achieve emissions compliance
• Analyze emission test data and resolve compliance gaps
• Support OBD, evaporative emissions, and durability requirements
• Interface with regulatory agencies during audits and reviews

Required Skills:

• Strong knowledge of U.S. EPA & CARB regulations
• Hands-on experience in automotive emissions certification
• Background in Powertrain / Engine Calibration
• Familiarity with 40 CFR Part 86 & Part 600
• Experience working in OEM environment (Ford preferred)

Preferred:

• Hybrid / Electrified vehicle certification experience
• Experience with certification tools & reporting systems
• Bachelor’s degree in Mechanical / Automotive Engineering

POSITION DESCRIPTION:

The Videographer plays a key role in shaping the visual storytelling of the brand by capturing and producing compelling video content that showcases tools in action, highlighting product innovation, and supporting marketing activities across North America. They collaborate closely with the marketing, creative, and product teams to create content for social media, digital platforms, events, and retail support. Through hands-on production and post-production, they elevate brand presence and reinforce the company’s positioning as an industry leader.

ROLES & RESPONSIBILITIES:

Video Production & Filming:

• Shoot high-quality footage of tools in use, testimonials, and product demonstrations in studio and on-location settings.
• Operate cameras, lighting, and sound equipment to ensure professional production standards.

Post-Production Editing:

• Edit raw footage into finished video content for various marketing channels.
• Apply motion graphics, music, voiceovers, and brand elements to align with company standards.

Pre-Production Planning:

• Work with stakeholders to plan storyboards, shot lists, and schedules.
• Scout locations, coordinate props, and ensure safety and compliance on set.

Brand & Visual Consistency:

• Maintain a consistent visual identity and tone across all video assets.
• Ensure each video aligns with brand guidelines and marketing goals.

Content Strategy Support:

• Collaborate with the marketing team to align video content with campaign objectives.
• Contribute creative ideas to enhance storytelling and increase audience engagement.

Tool Demonstrations & How-To Content:

• Capture hands-on tool usage to create engaging and educational content for end users.
• Ensure technical accuracy by working closely with product managers and trade professionals.

Social Media Integration:

• Produce short-form videos optimized for platforms like Instagram, YouTube, and TikTok.
• Stay informed on social trends to create timely, relevant, and shareable content.

Asset Management & Archiving:

• Maintain a well-organized library of video files, project assets, and raw footage.
• Ensure all content is properly tagged and accessible for future use.

Event Coverage:

• Film at trade shows, jobsite visits, and internal events to capture brand experiences.
• Deliver rapid-turnaround content to support real-time and post-event promotion.

Cross-Functional Collaboration:

• Partner with design, marketing, and product teams to understand content needs.
• Provide creative direction and technical insight during project briefings and reviews.

SKILLS & EXPERIENCE:

1. Proficiency in video production tools (DSLRs, mirrorless cameras, lighting, audio).
2. Expertise in editing software (Adobe Premiere Pro, After Effects, Final Cut Pro).
3. Strong understanding of framing, lighting, and audio for field and studio environments.
4. Ability to manage multiple projects with tight deadlines and changing priorities.
5. Experience shooting product and lifestyle content in industrial or rugged settings preferred.
6. Strong storytelling instincts with a passion for craftsmanship and tools.
7. Ability to lift and transport gear and work in physically demanding environments.
8. Knowledge of social video formats and platform requirements.
9. Excellent communication and teamwork skills.
10. 2+ years of experience in videography, preferably within a product, brand, or agency context.