Production Associate II Job at ITW (Mechanic Falls, Maine)

Clinical Research Associate II (CRA II) - Late Phase

We are seeking a Clinical Research Associate to join ICON Commercialisation & Ou...

Location

Italy , Milan

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine and Certification for monitoring trials
Experience as a Clinical Research Associate, ideally within late phase / Phase IV / real-world studies (1-2 years min)
Experience across both investigational product (IP) and medical device trials is highly desirable
Strong understanding of ICH-GCP, regulatory requirements, and post-marketing study environments
Proven ability to manage multiple sites and competing priorities
Expertise in site monitoring, data integrity, and risk-based monitoring approaches
Proficiency in clinical systems (e.g., CTMS, EDC)
Willingness to travel across Italy (~6–8 days per month)
Excellent communication, stakeholder management, and influencing skills

Job Responsibility

Site Monitoring & Oversight: Conduct on-site and remote monitoring visits across late phase studies, ensuring compliance with protocols, ICH-GCP, regulatory requirements, and applicable device regulations
Late Phase Study Delivery: Support execution of post-authorisation, observational, and interventional studies, ensuring high-quality data collection and real-world evidence generation
Site Performance & Issue Resolution: Evaluate site performance, identify risks, and implement solutions to ensure studies are delivered on time and to quality standards
Cross-Functional Collaboration: Partner with project teams, medical, data management, and commercial stakeholders to ensure efficient study delivery and reporting
Training & Mentorship: Provide guidance and support to site personnel and junior CRAs, maintaining consistency and best practice, where applicable
Stakeholder Engagement: Build strong relationships with investigators and site staff to drive engagement and successful study execution

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

New

Associate II, Quality (7pm-7am)

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent required. Must be at least 18 years of age
BS in engineering/science or equivalent work experience
3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry
Strong interpersonal skills and great attention to detail are necessary
Must be a strong team player with good problem solving, and good verbal and written communication skills
Must have the ability to manage people, encourage teamwork and drive decisions
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Must have basic English written and oral communication skills adequate to communicate with other team members

Job Responsibility

Leads ongoing, daily departmental operations
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner
Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions
Determine the logic, adequacy and effectiveness of processes, systems and related requirements
Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s)
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off

Fulltime

New

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites
Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Partner with SCP and the study team to define and support recruitment initiatives at site level

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

New

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent required. Must be at least 18 years of age
BS in engineering/science or equivalent work experience
Multiple years of experience in Quality with a medical device/Pharma company or other similarly regulated industry
Strong interpersonal skills and great attention to detail are necessary
Must be a strong team player with good problem solving, and good verbal and written communication skills
Must have the ability to manage people, encourage teamwork and drive decisions
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Must have basic English written and oral communication skills adequate to communicate with other team members

Job Responsibility

Serve as an SME for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics
Complete trending, APQR, and Management review process objectives
Utilize knowledge of software to compile and interpret data, and work with statistical and trending software to analyze data
Ensure compliance with all applicable SME-related Standard Operating Procedures (SOPs)
Participate in FDA inspections, preparing materials and interfacing directly with FDA
Ensure audit readiness of the area by researching background information, maintaining current and in alignment with procedures, and reviewing related audit results
Remain current in industry and regulatory trends in this SME area through attendance at related conferences, seminars, meetings, and other training methods
Participate in the development and delivery of GxP training programs, as needed
Work closely with production supervisors, quality, engineering, and other internal groups to accomplish the above and influence necessary actions
Write, review, analyze, and revise written Standard Operating Procedures (SOPs) to meet regulatory, corporate, and plant requirements

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
2 Days a Year to Volunteer

Fulltime

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
Prepares and publishes annual product reviews
Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results
Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks
Reports findings (verbally and written) to management

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Transaction Processor Associate II

We are seeking a detail-oriented Transaction Processor Associate II to join a fa...

Location

United States , East Hartford

Salary:

20.22 USD / Hour

MMC Group LP

Expiration Date

Until further notice

Requirements

Typing speed of at least 40 WPM
High attention to detail and accuracy
Strong data entry and computer skills
Excellent organizational and time management abilities
Ability to multitask and adapt in a fast-paced environment
Strong analytical and problem-solving skills
Ability to work independently after training
Professional communication skills

Job Responsibility

Process transaction and case maintenance requests accurately while following established procedures
Evaluate medical expenses and determine eligibility for medical programs
Enter and update consumer information within eligibility determination systems
Research and analyze information to ensure accurate case processing
Communicate with clients through written and verbal correspondence
Meet or exceed daily productivity and quality standards
Maintain accurate documentation and ensure compliance with project guidelines
Deliver exceptional internal and external customer service
Learn and utilize multiple computer systems and software applications
Complete assigned work within required deadlines

What we offer

Medical, dental, and vision coverage
Life and disability insurance
Additional voluntary benefits

Fulltime

Clinical Research Associate II

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Taiwan , Taipei

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
Willingness to work in a matrix environment

Job Responsibility

Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections
Collect, review, and approve updated/amended site documentation
Evaluate site recruitment plan in collaboration with the site staff

Transaction Processor Associate II

Transaction Processor Associate II - East Hartford, CT | Full Time | Monday thro...

Location

United States , East Hartford

Salary:

20.69 USD / Hour

MMC Group LP

Expiration Date

Until further notice

Requirements

Associate's degree or higher from an accredited college or university
Six months or more of call center or customer facing support experience
Experience processing eligibility or benefit determinations
Typing speed of 40 WPM or higher
Strong computer navigation skills
Excellent written and verbal communication
Ability to meet production and quality standards
Strong organizational skills
Ability to work independently after training
Commitment to accuracy and customer satisfaction

Job Responsibility

Assist families by providing professional, courteous telephone support
Process applications and consumer information accurately
Research, analyze, and update records using multiple computer systems
Screen applicants and enter information into program applications
Process denial letters according to established procedures
Document all customer interactions thoroughly and accurately
Communicate with clients through verbal and written correspondence
Meet daily productivity and quality goals
Resolve customer questions with empathy and professionalism
Support inbound customer service operations when needed

What we offer

Medical, dental, and vision coverage
Life and disability insurance
Additional voluntary benefits
Paid training

Fulltime

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Production Associate II

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