Quality Validation Associate Job at CK Group (Hatfield)

Process Validation Associate

This position reports to the Process Validation Manager and is responsible for m...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
Organizational and management skills to participate in multi-discipline project groups
Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate
Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations
Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations
Proficiency with technical writing expected
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point

Job Responsibility

Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages
Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes
Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits
Development and implementation of SOPs/Guideline documents with systemic procedural improvements
Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures
May participate on sub-teams
Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Participate in multi-departmental meetings & project teams
Identifies and assists with implementation of improvements to Process Validation systems (department level impact)
Generation of process validation master plans, core validation master plans and additional supporting documentation

Fulltime

FLEX Associate Quality Engineer

Temporary entry-level quality engineering role focused on supporting development...

Location

United States , Bethesda

Salary:

44.90 - 74.04 USD / Hour

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Experience in software testing
Undergraduate degree or equivalent experience/certification
Technology certifications
Experience in Agile methodologies

Job Responsibility

Collaborates with product team members on QE tasks and procedures
Functions as a working SDET where needed
Assists in setting best practice quality procedures
Reviews and edits product documentation
Drives the adoption of TDD, BDD and related test-first development methodologies
Performs quantitative and qualitative analyses for delivering automated testing processes and tools
Implements tooling such as Tosca, NeoLoad, Cucumber, etc.
Validates solutions with enterprise architecture team
Facilitates achievement of expected deliverables and obligations of Service Providers
Ensures proper coordination with appropriate IT and vendor teams

What we offer

Medical coverage
Dental coverage
Vision coverage
Health care flexible spending account
Dependent care flexible spending account
Life insurance
Disability insurance
Accident insurance
Adoption expense reimbursements
Paid parental leave

Fulltime

Quality Lab Associate I

Conduct microbiological analysis, perform endotoxin and particulate matter testi...

Location

United States , Marion

Salary:

56000.00 - 77000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science
2-5 years of experience or Master’s Degree in biological sciences with 0-3 years experience, preferably in the pharmaceutical or medical device industry
computer literate/knowledge of Microsoft office applications (Word, Excel)
proficient in quality based computer systems such as LIMS, POMS, Endoscan-V software, Sampler Sight Pharma, and AS400
attention to detail and ability to prioritize multiple tasks
proficient in the operation of laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing
good documentation skills and knowledge of GDPs (Good Documentation Practices)
knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
must be able to communicate effectively with supervisors and peers
must be experienced in executing general microbiology procedures

Job Responsibility

Prepare samples and perform endotoxin testing on raw materials, solution, and water for bioburden
perform particulate matter testing on solution
perform daily pH meter, balance, and pipette verification
perform daily Honeywell automated temperature checks and manual temperature monitoring
perform peptidoglycan and gel clot testing as needed
manage reagent inventory
generate monthly trend reports
calibration of micro-pipettes, analytical balance, water bath, dry heat bath, depyrogenation ovens, light obscuration particle counters and spectrophotometer
responsible for daily lab upkeep including cleaning, glassware washing and depyrogenation, supply replenishment, syringe and endotoxin prep
assist in method validation and protocol testing as needed

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
short-term and long-term disability insurance
Employee Assistance Program
childcare benefits

Fulltime

Validation Specialist

The role of the Validation Specialist is to implement and execute tasks relating...

Location

Ireland , Stamullen

Salary:

Not provided

PCI Pharma Services

Expiration Date

October 31, 2026

Requirements

Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation
minimum 2 years’ experience working in Manufacturing or Quality
Demonstrate interest in Validation
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets
Ability to manage multiple tasks and set priorities
Problem Solving and Troubleshooting skills
Self-motivated with a results driven approach
Flexibility to work across different shifts on request in line with business needs
Adaptable and ability to work collaboratively
Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)

Job Responsibility

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
Comply with Site Validation Master Plan
Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports
Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
Perform sampling in support of validation studies, including AQL, and cleaning validation
Manage tooling validations and associated documentation
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
Support complaint investigations, deviation investigations and change controls as required

Fulltime

Quality Project Manager

Nemera is a leading global manufacturer of complex drug delivery systems for the...

Location

United States , Buffalo Grove, Illinois

Salary:

120000.00 - 135000.00 USD / Year

Nemera

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or related field
4+ years of relevant working experience in Quality in a manufacturing environment
1+ year experience in a supervisory role
Excellent communication skill with the ability to understand, read, write, and speak English
Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Strong understanding of injection molding, Automation and FMEA
Knowledgeable to equipment/process/product validation practices and principles
Excellent interpersonal, organizational and communication skills
Demonstrated leadership and the ability to motivate and influence others
Able to lift up to 30 lbs

Job Responsibility

Assists Associate Director of Quality in coordinating and executing goals and objectives throughout the company to improve product quality and operating system efficiency
Direct and coordinate the activities of Quality Department employees
Establish and maintain sound relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions
Act as liaison with metrology, QC and compliance team
Ensure adherence to project and company standards, while maintaining quality systems that meet customer, internal, and regulatory requirements (ISO, cGMP, FDA, Health & Safety)
Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions
Manage process and equipment Validations for new product and existing business
Change control process owner
Define and implement quality initiatives to meet KPI’s and objectives
Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes

Fulltime

New

QA Validation, Senior Associate

Proclinical is seeking a Senior Associate, Quality Assurance Validation to provi...

Location

United States , Boston

Salary:

90.00 - 97.00 USD / Hour

Proclinical

Expiration Date

Until further notice

Requirements

A degree in Science, Logistics, or a related field is preferred
Strong knowledge of GxP regulations and ability to apply them to validation and operational activities
Hands-on experience in areas such as Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities Engineering, or Computerized Systems/Automation
Proficiency in managing change controls, deviations, and CAPA processes
Excellent cross-functional collaboration skills to drive compliant and practical outcomes
Highly organized and capable of managing multiple priorities in a team-oriented environment
Effective verbal communication skills to convey quality expectations clearly
Exceptional technical writing skills for validation and quality documentation
Adaptability and flexibility in a fast-paced, evolving environment
Continuous improvement mindset with a focus on innovation and process enhancement

Job Responsibility

Oversee the validation lifecycle, ensuring documentation accuracy, completeness, and compliance with regulations and internal procedures
Collaborate with teams across Validation Engineering, IT, Manufacturing, and other departments to develop and maintain risk-based validation strategies
Ensure validation activities align with regulatory expectations, including FDA, ICH, NIST, GAMP 5, and PIC-S guidelines
Provide quality input, review, and approval for change controls, deviations, CAPAs, and risk assessments to mitigate risks to product quality and data integrity
Promote inspection readiness through proactive issue identification and collaboration across GxP functions
Embed data integrity principles into all validation activities, systems, and documentation
Represent Quality Assurance Validation on project teams, offering strategic guidance and quality oversight
Utilize data-driven and risk-based methodologies to support effective validation outcomes
Demonstrate leadership behaviors that align with core values and foster a culture of quality and compliance

Quality Assurance

Location

Ireland , Dublin

Salary:

Not provided

Executive Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or Life Science related discipline
2+ years of Quality Assurance experience in a Life Sciences environment
Manage internal ISO quality process
Understanding of principles of Validation and New Product Introduction
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Proven experience participating in or leading audits and inspections

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations
Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents
Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
Review of executed validation documents and reports
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records
ensuring scope of record is clear and implementation activities are robust and timely
Perform all activities in compliance with company safety standards and SOPs

Fulltime

Senior Associate Quality Control - Nights

Play a key role in the Quality Control team as the Senior Associate QC night shi...

Location

United States , Holly Springs

Salary:

83951.00 - 100822.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience
Associate’s degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience
Bachelor’s degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience
Master’s degree
Experience working in a GMP-regulated Quality Control laboratory with proven ability to work independently

Job Responsibility

Execute QC night shift activities, working with the night shift team lead, including sample receipt, prioritization, and accurate entry into LIMS
Serve as a point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation
Independently perform routine and sophisticated analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required
Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements
Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership
Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS)
Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Quality Validation Associate

CK Group

Location:
United Kingdom , Hatfield

Category:
Pharmacy

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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