GMP Documentation Analyst Job at Mantell Associates (Buenos Aires)

GMP Manufacturing Analyst – Biologics

This is a technically demanding role that requires genuine hands-on manufacturin...

Location

Argentina , Buenos Aires

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Direct, hands-on experience working in large-scale biological manufacturing – floor-level production experience is essential
Strong technical knowledge of upstream and/or downstream bioprocessing at scale (500L bioreactor capacity or above)
Proven experience in the technical review of GMP batch records or manufacturing process documentation
Solid understanding of deviation management and discrepancy investigation processes
Experience within monoclonal antibody or biosimilar manufacturing highly desirable
Working knowledge of GMP principles and relevant regulatory frameworks (FDA, EMA, ANMAT or equivalent)
Ability to review documentation with a critical, process-informed eye – not simply a compliance checklist approach
Fluency in Spanish
working knowledge of English advantageous
Based in Buenos Aires with full-time on-site availability and able to work on a consultancy basis

Job Responsibility

Technical review of GMP batch records across large-scale biological manufacturing, covering upstream (cell culture, bioreactor operations) and downstream (purification, chromatography, filtration, formulation) processes
Identification, documentation and escalation of batch record discrepancies, incomplete entries and deviations, informed by a genuine understanding of the production process
Ensuring all manufacturing documentation meets GMP requirements, internal quality standards and regulatory expectations
Collaborating with manufacturing, QA and process development teams to resolve documentation issues efficiently
Contributing to the continuous improvement of batch record templates, documentation workflows and best practices

Fulltime

Qc Team Leader

As QC Team Leader you will play an important role within your team, developing y...

Location

United Kingdom , Dundee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Bachelor's degree in Science (Chemistry
Pharmacy
Biology) or equivalent experience
Proven track record of leading and developing a team of QC analysts
Strong knowledge of GMP and Global Pharmaceutical Regulations
Expertise in chemistry, laboratory techniques, and chromatography systems/software
Proficiency in analytical method development, transfer, and technical documentation (e.g., SOPs, reports)
Excellent communication, conflict resolution, and resource management skills
Strong Microsoft Office skills, particularly in Excel
A collaborative, solution-oriented mindset with a focus on continuous improvement

Job Responsibility

Champion Health and Safety by adhering to policies, reporting incidents, identifying risks, and promoting a strong safety culture
Support the Head of QC in cultivating a culture of quality, compliance, and continuous improvement (GMP, GLP, Data Integrity, Housekeeping)
Provide leadership and technical guidance to analysts, including training, coaching, development, mentorship, and ongoing performance management
Oversees the QC analysts' day-to-day operations
Ensure timely review and approval of QC testing across raw materials, in-process, finished products, stability, and validation samples
Oversee the closure of CAPAs, incidents, change controls, audits, SOPs, and method updates
Manage laboratory systems and processes to maintain efficiency and regulatory compliance
Participate in client and project meetings, ensuring seamless process management and timely invoicing
Maintain accurate planning and scheduling, including 12-week visibility and timely completion of PQRs
Ensure effective stability sample management and documentation

Fulltime

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

Software Development Senior Specialist

We are currently seeking a Software Development Senior Specialist to join our te...

Location

India , Noida

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred)
In-depth knowledge of laboratory operations (QC, stability, sample management, batch release)
Experience with LIMS integrations (ERP, instruments, CDS, MES)
Fluent or professional-level German (spoken and written) – mandatory
Excellent English and German communication and documentation skills
Strong presentation skills with the ability to confidently interact with senior client stakeholders
Proven experience in client-facing roles or consulting engagements
Ability to manage multiple stakeholders and align business and technical teams
Strong analytical, problem-solving, and decision-making skills

Job Responsibility

Act as the primary client-facing Business Analyst for LabVantage LIMS engagements
Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English
Build strong relationships with customer stakeholders across QC, QA, IT, and business teams
Clearly articulate solution designs, impacts, and benefits to non-technical audiences
Gather, analyze, and document business and functional requirements (URS, FRS, user stories)
Translate laboratory processes into LabVantage LIMS functional designs and workflows
Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities
Support LIMS configuration including workflows, master data, and role-based access
Ensure all solutions comply with GMP, GxP, and data integrity principles
Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices

Fulltime

Assistant Scientist - QC Micro

Proclinical is seeking an Assistant Scientist - QC Micro to support the testing ...

Location

United States , Zebulon

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology or Biology
Proficiency in using laboratory instrumentation and techniques such as HPLC, Vitek, GC, UV, and microscopy
Strong understanding of GMP standards and analytical testing procedures
Ability to interpret and evaluate data accurately
Experience in troubleshooting laboratory equipment and documenting processes
Effective communication skills for reporting deviations and collaborating with team members
Capability to train others and contribute to cross-functional projects

Job Responsibility

Perform routine analytical testing on raw materials, packaging components, finished products, and environmental samples using approved methods and instruments (e.g., HPLC, Vitek, GC, UV, microscope, Gram stainer, robotics)
Generate reliable, compliant data while meeting productivity expectations and following cGMP requirements
Interpret, assess, and validate analytical results to ensure accuracy and consistency
Report any deviations or critical findings from analytical testing to the supervisor or designated contact
Review and evaluate data produced by other analysts within the laboratory team
Accurately document analytical results and review laboratory documentation, including SOPs, technical reports, methods, and specifications
Maintain, calibrate, and troubleshoot laboratory equipment to ensure proper performance
Support the training of laboratory staff on analytical methods, instrumentation, and relevant computer systems
Contribute to cross‑functional project teams or committees when required
Understand data integration workflows and perform accurate calculations of results

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

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

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GMP Documentation Analyst

Job Description

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