Compliance Associate II Job at PCI Pharma Services (San Diego)

Compliance Associate II

Perform moderately complex activities pertaining to assuring compliance with app...

Location

United States , San Diego

Salary:

32.92 - 37.04 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences discipline or equivalent preferred
Minimum of two to four (2-4) years of experience in a GMP environment
Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing
Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification
Developing communication and team collaboration skills
Detail-oriented with strong organizational skills
Proficient with Microsoft Office applications

Job Responsibility

Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions
Assists with vendor quality program by conducting paper audits and tracking vendor quality issues and changes
Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions
Assists with regulatory inspection process by retrieving requested documentation and communicating with SMEs
Regular and reliable attendance on a full time basis
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture

What we offer

Annual performance bonus
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan

Fulltime

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

Clinical Research Associate II (CRA II)

As a CRA II at ICON, you will design and analyse clinical trials, interpreting c...

Location

China , Shanghai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Willingness to travel as required (approximately 60%)

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication skills in German and English
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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

Senior Clinical Research Associate or Clinical Research Associate II

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 1-year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Ability to travel at least 60% of the time (international and domestic - fly and drive)

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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

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

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Compliance Associate II

Job Description

Job Responsibility

Requirements

What we offer

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