Quality Validation Associate Job at CK Group (Hatfield)

1st Shift Associate Quality Engineer

We are launching people to the Moon and Mars. If you want to be part of this ama...

Location

United States , Kennedy Space Center

Salary:

Not provided

Amentum

Expiration Date

Until further notice

Requirements

Bachelor of Science (BS) in Engineering or technical equivalent from an accredited institution, at least 4 years of experience
Must have a valid US Driver's License
Requires experience in the area of Quality or other technical role
Excellent communication, presentation and customer interface skills required
Ability to manage and prioritize multiple projects without missing deadlines or sacrificing accuracy
Ability to work effectively and cooperatively in a team environment
Must be self-motivated, demonstrate initiative, and be able to work independently or with minimal supervision
Must be able to coordinate work between multiple project disciplines
Experience with manufacturing or operations a plus
Computer experience with Microsoft Office products, Internet browsers, and outlook

Job Responsibility

Establish/assess quality performance criteria in the execution of Program requirements
Develop/establish/maintain processes and metrics that support contract and AS9100 requirements
Contribute technically to Design/Project Reviews, V&V assessments, and Technical Boards
Reviews work documents and procurement documents to ensure proper application of inspection requirements
Creates, updates and validates Acceptance Data Packs
Initiate, follow-up, and ensure closure of non-conformances
Obtain/maintain MR/MRB certification and support technical assessment of nonconforming products
Develops sampling plans
Maintains statistical process controls
Analyzes data by completing hypothesis testing (ANOVA) and process capability analysis tests

What we offer

Health, dental, and vision insurance
Paid time off and holidays
Retirement benefits (including 401(k) matching)
Educational reimbursement
Parental leave
Employee stock purchase plan
Tax-saving options
Disability and life insurance
Pet insurance
Child Development Center

Fulltime

Quality Associate III

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

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

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 starting on day one
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Associate Quality Control (Analytical)

Amgen is one of the world's leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR Associate's Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience
1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred
Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Experience with Quality Control testing and laboratory operations for common testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA Testing)
Good communication skills (technical writing and verbal communication/ presentation)
Interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation
Responsible for maintenance of chemicals and consumables inventory
Ensure proper handling, storage, disposal of all chemicals used in the lab
Responsible for laboratory housekeeping and document archival duties
Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Participate in method verification and method validation/ transfer for new product introduction (when required)
Perform review of laboratory data/ records
Assist in SOP/ protocol/ report writing
Assist in periodic review of laboratory procedures and risk assessment

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Quality Associate III

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master’s degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

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
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

As a Quality Associate III – QC Microbiology, you will support microbiological q...

Location

United States of America , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

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
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

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

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

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

Manufacturing Validation 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 Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software
Some experience with statistical software helpful

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

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
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Manufacturing Validation Associate II

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful
Direct or indirect industry knowledge

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

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

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Quality Validation Associate

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