Quality Associate I

Senior Quality & Reliability Engineer

QE Specialist

Quality Engineer

Senior Microbiology Technician

QC Laboratory Manager

Field Application Engineer

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

MFG & Process Development Engineer II – Molding

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills / Competencies <ul><li>Strong knowledge of 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Job Overview: <ul><li>Prepares the technical proposals, defines technical solutions and other guidelines and provides technical and administrative consultation and support to the field service staff and customers for products.</li></ul> Responsibilities: <ul><li>Read and interpret product drawings and descriptions</li><li>Prepare technical documentation for commercial offers, public and private bids</li><li>Follow up on services provided to customers</li><li>Create technical product presentations</li><li>Provide technical support for projects and quotations</li><li>Offer technical assistance, product information, and application solutions to meet customer expectations</li><li>Update technical product documentation (specifications, tests, installation instructions, assembly instructions, etc.)</li><li>Maintain contact with Engineering departments, Product Managers, and Customer Service teams.</li><li>Responsible for these activities in Argentina</li><li>Availability to travel.</li></ul> Requirements:&nbsp; <ul><li>Knowledge and application of the company’s quality system</li><li>Ability to apply procedures for continuous improvement</li><li>Familiarity with product catalog (electrical)</li><li>Intermediate English proficiency</li><li>Intermediate skills in spreadsheets, word processing, and presentations</li><li>Acrobat PDF Editor</li><li>Use of manual tools | - Teamwork</li><li>Strong interpersonal skills</li><li>Perseverance and patience</li><li>Proactive, organized, and methodical</li><li>Experience on electrical sector</li><li>Able to Travel Paraguay &amp; Uruguay</li></ul>

Responsibilities: Regulatory Support: Innovation:&nbsp; <ul><li>Work closely with R&amp;D and business partners regarding regulatory matters.&nbsp;</li><li>Work closely with Product development, marketing, legal and all relevant teams to ensure local regulatory and external requirements, restrictions and risks are identified, accurate, relevant and timely input given to innovation projects. (These could be in areas of claims, labelling, permitted additives/formulations, new product regulations.)</li><li>Performs regulatory compliance assessments for the markets of scope.</li><li>Performs technical registrations across markets of scope through preparing registration files and applying at the government bodies responsible for registration.</li></ul> Advocacy: <ul><li>Understands external environment and regulatory developments, supports building lobbying plans, advocacy priorities and actions aligned with relevant interfaces (legal, R&amp;D.)</li><li>Provides RA input on the topic and helps to implement the communication plan with other functions locally.</li><li>Implement advocacy plans for regulatory changes or new product regulations.</li><li>Represent the function in external platforms on technical issues, lobby activities and approvals to support aligned and agreed lobby/advocacy topics.</li></ul> Wellbeing Support: <ul><li>Propose / calculate the nutrition facts of recipes/breakfasts/snacks with our products, comparison with other traditional options.</li><li>Assist in compliance with nutrition regulations and self-governance, localization of substantiation for claims (TV, print, web, POS).</li><li>Management of a nutrition database of products in the region, populating it with renovations and innovations</li></ul> Requirements: <ul><li>A Scientific degree (Pharmacy, Science.), a nutrition degree is a plus.</li><li>Should have a minimum of 1-3 years of experience in Regulatory Affairs/Nutrition Function in a Food Industry.</li><li>Ability to be a team player in support of the team and the business.</li><li>Ability to organize and coordinate</li><li>Ability to work in a high-pressure environment with tight deadlines</li><li>Analytical thinking with the ability to plan, prioritize and deliver results&nbsp;</li><li>Knowledge of the health agenda in food and nutrition and awareness of key players in the Reg and wellbeing debate&nbsp;</li><li>Commercial interest with the ability to demonstrate a committed approach to delivering for the customer and consumer.</li><li>A confident communicator capable of presenting.</li><li>Good Language Skills / Vocabulary in written and spoken English and preparation of Techno legal drafts.</li><li>Any other languages like French is a good to have.</li></ul> Work Environment: <ul><li>Based in Cairo.</li><li>Internal Relationship: Legal, Marketing, supply chain, Corporate Affairs, R&amp;D.</li></ul>

Responsibilities: <ul><li>Overall molding process development, coordinating with interaction processes (Stamping, Plating, Assembly) to ensure the best process and cost for F/Gs</li><li>Concept design &amp; proofing for Molding process and tooling, Process development DOE.</li><li>Technical leader and trouble shooter from LVM to HVM in process development, tooling design &amp; qualification, issue finding and problem solving</li><li>Platforming manufacturing process development.</li><li>Challenge product design for manufacturability and cost feasibility.</li><li>Launch product at rate through FACA/QCPA tools (yield, CPK, OEE…)</li><li>Launch product on time with cross function team.</li><li>Process documentation (DFM，FMEAs, WI, FACA/QCPC…)</li></ul> Requirements:﻿ <ul><li>Bachelor or above degree in mechanical engineering or related background.</li><li>5+ years Mold design, Process and Troubleshooting knowledge / experience.</li><li>Strong knowledge of tool fabrication, tool-steel application/selection, heat treating, and plating/coating.&nbsp;</li><li>Strong knowledge of injection molding processes (Injection, Insert-molding, two-shot, etc.).</li><li>Strong understanding of plastic, injection machine, auxiliary equipment (strip feed, camera, etc).</li><li>Good at Mold flow simulation and analysis.</li><li>Familiar with BTI 5-Step process, and Knowledge of SIM (Scientific Injection Molding).</li><li>Understand tolerance calculations and Geometric Dimensioning and Tolerancing.</li><li>Data oriented issue finding and problem-solving skills.</li><li>Rich shopfloor hand on experience.</li><li>Sensitive on product cost, know how to drive cost through manufacturing process development &amp; design optimization.</li><li>Fluent in using of basic process development related tools like DFM, PFMEA，DOE，FAA, CTAR，CAD，Pro E</li><li>Knowledge of quality control and quality issue analysis and improvement</li><li>Good teamwork and communication skills。</li><li>Fluent in written and Spoken English.</li><li>Oversea working experience is a plus</li></ul>

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9 scientific editor Jobs found

Quality Associate I

Senior Quality & Reliability Engineer

QE Specialist

Quality Engineer

Senior Microbiology Technician

QC Laboratory Manager

Field Application Engineer

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

MFG & Process Development Engineer II – Molding

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Skills

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9 scientific editor Jobs found

Quality Associate I

Senior Quality & Reliability Engineer

QE Specialist

Quality Engineer

Senior Microbiology Technician

QC Laboratory Manager

Field Application Engineer

Regulatory and Wellbeing Affairs Assistant Manager/Specialist

MFG & Process Development Engineer II – Molding

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.