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

New

Sr. Analyst, Quality Systems

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

Location

United States , Saint Paul

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Strong verbal and written communication skills
Effective documentation practices
Ability to engage confidently across all levels of the organization
Drives continuous improvement of procedures and processes
Simplifies complexity, increases efficiency, enhances usability across Quality Systems
Interprets and applies quality system regulations
Ensures compliance
Translates regulatory requirements into practical, site-ready solutions
Maintains relevant professional certifications (e.g., CQA, ISO 13485 Auditor) or actively works toward certification
Fosters collaborative, team-oriented environment

Job Responsibility

Own and continuously improve the site Quality Management System (QMS)
Lead the implementation, administration, and ongoing effectiveness of Quality Systems
Drive document control excellence by authoring, reviewing, and approving controlled documents
Manage and enhance the training program
Ensure site-wide compliance readiness by coordinating internal and external audits
Lead Management Review processes
Own the Change Control process
Develop, monitor, and communicate Quality System metrics
Interpret and communicate QMS KPIs
Author, review, and continuously improve SOPs and controlled documents

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 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

FS Administration Analyst, EMEA

As FS Administration Analyst, you will be responsible for helping to ensure the ...

Location

United Kingdom , London

Salary:

Not provided

Reinsurance Group of America

Expiration Date

Until further notice

Requirements

Intermediate Excel proficiency: Data retrieval functions e.g. VLOOKUP, IF statements, SUMIF, COUNTIF, Text Functions e.g. LEFT, RIGHT, MID, TRIM. Date and Time functions e.g. TODAY, WEEKDAY. Data Management and Analysis functions e.g. pivot tables, sorting and filtering, conditional formatting, removing duplicates.
Analytical thinking and problem solving: Detail-oriented with a focus on accuracy.
Experience working with large data sets
Knowledge of pensions including individual annuities and defined benefit schemes, GMP, Revaluation etc.
Previous pensions administration experience.
Basic VBA/Macros Knowledge
CII Qualifications (LF1) or equivalent work experience.

Job Responsibility

Work collaboratively with other team members and other RGA functions i.e. Finance Valuation, Risk, Treasury to ensure accurate and timely administration of treaties in line with SOX requirements, establishing strong relationships with individuals and teams in these functions
Contribute to a culture of continuous process improvement
identifying opportunities for automation and removal of procedures/processes that are not adding value
Ensure that the company’s administration standards and time service requirements are applied to the handling of all business received
Ensure that the administration of all UK business adheres to RGA treaties
For your specific client responsibility, provide administration data for input to accounting records, valuation systems and regulatory returns
Ensure reporting month end deadlines are met. This includes working with team members to ensure data can be processed in a timely and accurate manner to achieve this goal
Ensure administration data is provided to retrocession clients in a timely and accurate manner
Attend Client Audits/Assurance Reviews as and when required
Ensure administration processes and procedures are fully documented

What we offer

Gain valuable knowledge from and experience with diverse, caring colleagues around the world
Enjoy a respectful, welcoming environment that fosters individuality and encourages pioneering thought
Join the bright and creative minds of RGA, and experience vast, endless career potential

Fulltime

Lab Technician

Passion for quality, accuracy, and making an impact? We’ve got the perfect spot ...

Location

Netherlands , Leiden

Salary:

2886.00 - 3043.00 EUR / Month

Randstad

Expiration Date

June 06, 2029

Requirements

Completed MLO or HLO or equivalent laboratory education
Enjoy performing routine tests in the lab
Take initiative and work with high precision
Enjoying the balance between teamwork and independent tasks
Proficient in both written and spoken English

Job Responsibility

Perform lab tests including PCR, Cell Culture, BioFire, and Virus/Mycoplasma assays
Follow GMP Guidelines strictly to ensure safety and quality
Maintain precise documentation
Review test data
Collaborate with fellow colleagues, analysts and supervisors

What we offer

A salary between €2886,- and €3043,- per month
A workplace at an international organization
A diverse and pleasant work environment
Professional development opportunities
In Leiden on Bio-Science park
Reimbursement for public and own transportation
36 holiday days per year (based on full-time employment)
Full travel reimbursement for both public transport and private travel
Immediate enrollment in the Randstad pension plan
Unlimited access to free online training via GoodHabitz

Fulltime

Quality Control Validation Analyst

Join our team as QC Validation Analyst and start a new adventure in an internati...

Location

Italy , Latina

Salary:

26000.00 - 50000.00 EUR / Year

Amaris Consulting

Expiration Date

Until further notice

Requirements

2-3 years of experience with HPLC analysis using Empower3 software
Knowledge of cGMP and QC laboratory procedures in the pharmaceutical industry
Academic background: Degree in Chemistry, Pharmaceutical Chemistry and Technology or related field
Experience in analytical method validation in a GMP-regulated chemistry laboratory
Fluent Italian and good command of English
You have an ability to work precisely and efficiently in a regulated environment

Job Responsibility

Perform chemical analysis using HPLC with Empower3 software
Execute and document QC testing activities in compliance with GMP guidelines
Design and execute validation protocols for analytical methods (e.g., HPLC, GC, UV-Vis) in compliance with ICH and GMP guidelines
Perform validation experiments to assess accuracy, precision, specificity, linearity, range, detection and quantitation limits, robustness, and system suitability
Prepare and review validation documentation, including protocols, reports, and risk assessments
Support method transfer and verification activities between laboratories or from R&D to QC
Collaborate with cross-functional teams to ensure product quality compliance

What we offer

An international community bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
Strong commitments to CSR, notably through participation in our WeCare Together program

Fulltime

Document Control Analyst

Piper Companies is looking for a Document Control Analyst to join a large pharma...

Location

United States , Gaithersburg

Salary:

50000.00 - 65000.00 USD / Year

Piper Companies

Expiration Date

Until further notice

Requirements

1-4 years of document control experience
GMP knowledge required
Experience with TMF (trial master file)
Experience with paper-based and/or electronic document control systems
Education: Minimum High School Diploma
Associate’s or Bachelor’s degree preferred

Job Responsibility

Support quality systems and document control processes, ensuring compliance with Good Manufacturing Practices (GMP)
Ensure documents comply with established formatting and quality standards
Manage document lifecycle activities in the Document Management System (DMS), including implementation, user notifications, and controlled copy issuance and reconciliation
Perform record management tasks such as issuing, reconciling, scanning, and archiving

What we offer

Cigna Medical
Cigna Dental
Vision
401k w/ ADP
PTO
paid holidays
Sick Leave as required by law

Fulltime

Db Senior Technical Transaction Analyst

This is a key role within the Defined Benefit Solutions area to support the oper...

Location

United Kingdom , Reigate

Salary:

Not provided

Social Value Portal Ltd

Expiration Date

Until further notice

Requirements

Excellent Defined Benefit technical knowledge
Ability to work on own and to tight deadlines, maintaining exceptional standards of accuracy and attention to detail
Good organisational and prioritisation skills
Good verbal, written communication and interpersonal skills
Good analytical and issue resolution skills
An understanding of project management would be beneficial, but not essential
An understanding of DB pensions and/or Bulk annuities, pension scheme administration requirements and systems would be beneficial, but not essential

Job Responsibility

Produce consistent benefit specification documentation for all new transactions
From exclusivity, or contract signing stage for small schemes, ensure data is in place within the member factors tool to enable member options to be produced
Assessment of data, which includes pricing assumptions where required, to create initial data templates for the transition team
Through analysis of contractual terms, update Flo to reflect contractual delivery dates for member option deliverables
Working alongside Post Transaction Services Manager, to provide or support assessment of each new scheme to understand complexity and support needs for the data cleanse activity
Support GMP Equalization work by preparing templates when required

What we offer

A competitive salary, pension scheme and life assurance
25 days annual leave plus an additional day on us for your birthday
Private medical cover and income protection, just in case
A generous and highly achievable bonus scheme
Opportunities to progress your career in-role and within the company
Free access to the Headspace app, 24/7 employee assistance helpline and trained physical and mental health first aiders
A variety of employee funded benefits available via our online benefits portal
Plus, several additional purchase options available for you and your loved ones

Fulltime

Analyst Iii, Quality Lab-Microbiology

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

Location

United States , Hayward

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science experience
with minimum of 5 years’ experience, or Master’s Degree in Chemistry or biological science with 1-4 years’ experience.
Knowledge of microbiology and environmental monitoring (Endotoxin, Bioburden, and EM monitoring test)
Demonstrates some knowledge of assays/equipment in functional area. Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
Proficient use of laboratory equipment and tools. Must be detail-oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.
Must be able to learn new computer systems and programs in a timely manner.
Strong leadership, organization and time management skills.
Attention to detail and ability to prioritize multiple tasks in a timely manner.
Effective organizational skills and ability to plan and suggest resolutions to technical problems.
Strong data analysis and report writing skills.

Job Responsibility

Conduct Microbiological analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
Testing as required supporting Endotoxin testing, Bioburden analysis, microbial identifications, biological indicators, growth promotion, water.
Perform microbial and particulate monitoring of clean rooms throughout the facility.
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms.
Perform equipment maintenance and calibrations as required.
Maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
Write and execute validations for manufacturing processes and laboratory instruments and methods.
Work on special projects / protocol testing that involves new methods and instrumentation.
Investigate deviations and write nonconformance documents
Lead and/or actively contribute to a team setting within the laboratory to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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GMP Documentation Analyst

Job Description

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