GMP Documentation Analyst Job at Mantell Associates (Buenos Aires)

Quality System Analyst

On behalf of our client, we are looking for a QS Analyst (Training & Document Co...

Location

Switzerland , Le Locle

Salary:

Not provided

Randstad

Expiration Date

February 28, 2026

Requirements

Minimum of 1-2 years' experience in document and promotional materials management using electronic document management systems (Agile or Adaptiv or other PLM system)
Minimum of 1-2 years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device or pharmaceutical industries
Minimum of 1-2 years' experience in a Learning Management System (LMS) and its use to deploy training programs and requirements across the company
Knowledge or experience working in an FDA and/or European regulatory environment
Thorough understanding of GMP (Good Manufacturing Practices)/ISO (International Organization for Standardization) regulations
Written and verbal effective communication skills in English and in French including presentations as assigned
Proficient in Microsoft Office tools - Word, Excel, and PowerPoint
Solid document management skills
Strong communication, organizational, negotiation and interpersonal skills
Autonomous / Conscientious / Rigorous / Analytical Mind / Flexible

Job Responsibility

Manage and maintain the electronic training system (assignment, data entry)
Support the maintenance of the document control system
Manage circulation of documents for approval
Review electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
Maintain revision and approval status of all documents
Maintain appropriate form templates for access
Participate in quality system management
Coordinate classroom training sessions
Support during internal and external audits with the required training records or information
Create documentation & procedures related to its position

Fulltime

!

QC Analyst

Are you a QC Analyst/Analytical Chemist based in Central Belt of Scotland lookin...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree or equivalent in a relevant scientific discipline
Experience in QC Analytical techniques such as UV, HPLC, FTIR
Previous effective experience in a similar environment is essential
Prior experience working in a regulated GxP environment

Job Responsibility

Use a range of analytical chemistry techniques- predominantly HPLC
Ensuring all analysis and documentation are conducted and recorded in compliance with GMP standards
Working to set protocols within a busy environment
Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
Checking and reviewing of data in compliance with Data Integrity requirements
Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner
Perform stability study programme activities, storage of in process, and final products samples and retention sample management
Supporting the team leader where required

What we offer

bonus scheme
healthcare
flexi-time
shift bonus

Fulltime

PAS-X MES Business Analyst

We ensure that all operations, digital or otherwise, meet the latest quality and...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Master’s degree in Business Administration, Information Technology, Biopharmaceuticals or a related field
3-5 years of relevant work experience
Proven experience as a Business Analyst, preferably in a GMP environment
Knowledge of a pharmaceutical manufacturing process, including batch processing, recipe management, and quality control
Ability to write functional specifications
Affinity with automation, software, data and programming
Ability to work collaboratively with cross-functional teams to lead and deliver projects end-to-end
Proficient in using business analysis tools and software
Excellent analytical and problem-solving skills
Excellent networking and communication skills

Job Responsibility

Gathering, analysing and documenting requirements for electronic Master Batch Record (eMBR) changes within the PAS-X Manufacturing Execution System (MES)
Collaborating with cross-functional teams, including engineering, quality assurance, and operations, to ensure that the eMBR enhancements align with business goals and regulatory requirements
Gathering and analysing business requirements, creating detailed specifications, and acting as a liaison between business and technical teams

What we offer

Mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
The opportunity to connect with fellow Sopra Steria colleagues at various team events

Fulltime

QC Analyst

Are you a QC Analyst/Analytical Chemist based in Central Belt of Scotland lookin...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree or equivalent in a relevant scientific discipline
Experience in QC Analytical techniques such as UV, HPLC, FTIR
Previous effective experience in a similar environment is essential
Prior experience working in a regulated GxP environment

Job Responsibility

Use a range of analytical chemistry techniques- predominantly HPLC
Ensuring all analysis and documentation are conducted and recorded in compliance with GMP standards
Working to set protocols within a busy environment
Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
Checking and reviewing of data in compliance with Data Integrity requirements
Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner
Perform stability study programme activities, storage of in process, and final products samples and retention sample management
Supporting the team leader where required

What we offer

bonus scheme
healthcare
flexi-time
additional shift bonus

Fulltime

New

Manufacturing Analyst

This opportunity offers the chance to join a globally recognized biosimilars CDM...

Location

Argentina , Buenos Aires

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Experience within a biopharmaceutical manufacturing or related production environment
Strong knowledge of GMP requirements and manufacturing documentation standards
Demonstrated ability to review and interpret Batch Records, raw data, and QC results
Excellent organizational skills with strong attention to detail
Effective communication skills and the ability to collaborate cross-functionally
Availability to work on-site in Buenos Aires, 5 days per week

Job Responsibility

Support day-to-day production activities and ensure accurate and timely documentation of Batch Records
Review raw manufacturing data and QC results to confirm compliance with approved manufacturing specifications and GMP standards
Assist in investigations related to deviations, OOS/OOX events, and non-conformances, ensuring appropriate documentation and follow-up actions
Collaborate closely with QA and QC teams to maintain GMP compliance across manufacturing processes
Contribute to the preparation and participation in internal and external audits
Support continuous improvement initiatives within production operations to enhance efficiency, compliance, and documentation accuracy
Ensure manufacturing documentation is complete, traceable, and aligned with internal procedures and regulatory requirements

Qc Analyst

SRG are currently working with a global pharmaceutical manufacturer based in Liv...

Location

United Kingdom , Speke, Liverpool

Salary:

15.25 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Degree qualified in Chemistry, Biochemistry, Biomedical Science or a related scientific discipline
Demonstrated practical experience
Prior industrial experience in a GMP regulated environment is highly desirable
Knowledge of pharmacopoeias
Skills performing raw materials testing highly desired
Strong verbal & written communication skills

Job Responsibility

Perform analytical, biosafety & cell science testing on raw materials, intermediates and finished products
Complete laboratory documentation accurately and in accordance with industry regulatory standards
Utilise technical expertise to troubleshoot various assays as required

Fulltime

New

Senior Quality Control Analyst

We are looking for a highly skilled, hands-on Senior Quality Control Analyst to ...

Location

Canada , Vancouver

Salary:

88000.00 - 110000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep, hands-on Microbiology experience in a regulated (GMP) QC environment
Experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments
8+ years of hands-on QC microbiology experience in a GMP setting
Bachelor’s degree in Microbiology or a related life sciences field
Clear communication, collaboration, and calm, structured decision-making under pressure
Strong ownership, accountability, and a solutions-focused mindset
Organized, detail-oriented, and committed to inspection readiness and data integrity
Thrives in an environment requiring in-lab leadership, cross-functional coordination, and prioritization of operational needs

Job Responsibility

Leading Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending
Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution
Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices
Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness
Coordinating stability pulls, sample preparation, testing, and data tracking across QC programs
Overseeing sample receipt, chain-of-custody, aliquoting, storage conditions, and distribution workflows
Supporting routine sampling, testing, and trending of Utilities (WFI, clean steam, compressed gases) with appropriate documentation
Reviewing micro data packages, protocols, reports, and testing documentation for accuracy and adherence to ALCOA++ principles

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

QC Analyst II

Performs analyses of Clinical Chemistry, Critical Care, Coagulation and/or Micro...

Location

United States , Orangeburg

Salary:

24.00 - 29.00 USD / Hour

werfen

Expiration Date

Until further notice

Requirements

B.S./B.A. Degree in Science or Medical Technology or equivalent required
2 years clinical laboratory experience with a basic knowledge of quality control principles
Ability to lift and move materials per current OSHA standards

Job Responsibility

Performs automated and manual assays as detailed in departmental/plant SOPs and QC Monographs including raw material, in-process and finished product
Interprets test results against specifications and decides if assays pass or fail
Maintains documentation of all work performed in accordance with GMP requirements
Evaluates product complaints upon Team Leader or Team Champion's request
Performs product stability, proficiency, environmental testing and water system testing
Responsible for routine preventive maintenance, general trouble shooting, general cleanliness and calibration of Lab equipment
Updates departmental SOP's and QC Monographs as directed by Team Leader or Senior QC Analyst
Performs microbial testing per SOP's and QC Monographs
Orders required laboratory supplies, reagents and other consumables
Monitors proper storage conditions and expiration dates

Fulltime

GMP Documentation Analyst

Mantell Associates

Location:
Argentina , Buenos Aires

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 17, 2026

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Job Description:

Job Responsibility:

Requirements:

Additional Information:

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