Procurement Operations Manager

Quality Associate I

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

QC Chemist

Microbiology Technician

HR Manager

Manager – ADL GMP

Manager, Operations

Senior Quality Specialist, LIMS Administration

Responsibilities: Primary Function : <ul><li>Lead the procurement function for Pringles plant at Bandar Enstek, Malaysia. Act as focal point between regional procurement and local plant team</li><li>Manage all local procurement activities, including ad hoc sourcing, negotiations and contracting for items not in scope for regional category manager, issue resolution, local supplier management, shipment expediting, materials claim management and etc.</li><li>Support the sourcing strategy of the regional and global procurement sourcing team.</li><li>Connect plant stakeholders with MSP (managed service provider) for IDM STP support (Source-to-PO)</li><li>Advocate the global procurement policies (GPP) and responsible to educate the BU requesters on the GPP policy and compliances</li><li>Work with BU stakeholders, Category Managers, Process and Systems Lead, Procurement Operations Lead to identify efficiency and cost reduction opportunities</li><li>Manage supplier relationship and performance</li></ul> Principal Duties &amp;&nbsp;Responsibilities : <ul><li>Deliver upon targets and KPIs set by snacks supply chain and regional procurement</li><li>Attend plant supply chain deployment meetings</li><li>Comply with GMP and continuously improve our Food Safety Programme</li><li>Participate in Regional Sourcing activities and ensure regional / local execution knowledge and strategic input</li><li>Lead the execution and implementation of procurement sourcing strategy</li><li>Leverage regional procurement team to drive values</li><li>Aid in local supplier searches</li><li>Manage interactions with key suppliers</li><li>Manage financial reporting of procurement function</li><li>Manage transactional coordinators and balances workload within the team</li><li>Ensure compliance with policies and procedures</li><li>Deliver policy and process trainings to key stakeholders</li><li>Work closely with key customers to communicate process</li><li>Use data from Process and Systems team to set targets and drive KPIs</li><li>Work with shared services to standardize and automate tactical activities over time</li><li>Suppliers KPIs and service quality and performance improvement plan</li></ul> Requirements: Professional : <ul><li>Undergraduate Degree Required and minimum of 7 years of related work experience within Procurement</li></ul> Technical/Functional: <ul><li>More of Procurement generalist than a specialist.</li><li>Knowledge of order to payment technologies (P2P, SAP) and other procurement digital tools.</li><li>Sound procurement skills (negotiation, supplier management).</li><li>General knowledge of the supplier market in associated country.</li><li>Comprehensive knowledge of purchasing and basic understanding of supply chain management.</li><li>Financial tracking and reporting skill.</li><li>Team player.</li><li>Passionate about process improvement.</li><li>Strong detail orientation.</li><li>Excels at continuous cost reduction/process improvement.</li><li>Excellent communication skills.</li><li>Strong stakeholder management skill.</li><li>Effective at cross-functional teamwork.</li><li>Computer literate with working knowledge of Microsoft Office including Word, Powerpoint and Excel.</li><li>Ability to navigate with ambiguity.</li><li>Ability to multi-task in a fast paced environment.</li><li>Ability to work independently and with a sense of urgency.</li><li>Comfortable with conflict.</li><li>Strong service oriented approach, with timely responsiveness.</li><li>Ability to engage and collaborate with team members and stakeholders from a distance.</li></ul>

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>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: <ul><li>Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.</li><li>Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.</li><li>Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.</li><li>Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.</li><li>Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.</li><li>Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.</li><li>Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.</li><li>Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.</li><li>Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.</li><li>Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience working in sterile environments or supporting aseptic processes preferred.</li><li>Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.</li><li>Knowledge of cGMPs, data integrity principles, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and commitment to data accuracy and integrity.</li><li>Ability to work independently while collaborating effectively within a team</li><li>Good time management and organizational skills to support multiple tasks and priorities.</li><li>Proficient in the use of Microsoft Office and basic laboratory software systems.</li><li>Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.</li><li>A proactive and patient-focused mindset with a strong sense of ownership and compliance.</li></ul>

Responsibilities: <ul><li>Lead the HR function at the site to support business objectives and compliance with HR best practices.</li><li>Serve as a trusted advisor to site leadership on workforce planning, employee relations, and organizational development.</li><li>Partner with corporate HR, Quality, EHS, and Operations to align policies, procedures, and culture-building initiatives.</li><li>Initiate and nurture a positive employee relations environment through coaching, communication, and conflict resolution.</li><li>Ensure compliance with federal, state, and local labor laws, as well as cGMP and safety-related employee policies.</li><li>Maintain accurate and confidential employee records, including training and medical surveillance, in cooperation with the EHS Lead.</li><li>Develop, implement, and manage the Learning Management System (LMS) for GMP and technical training.</li><li>Implement employee engagement strategies to nurture a culture of integrity, teamwork, and compliance.</li><li>Administer compensation and benefits programs, including health, retirement, and wellness plans</li><li>Manage payroll coordination with Finance team.</li><li>Monitor and report on key HR metrics (e.g. headcount, turnover, training compliance, absenteeism, engagement)</li><li>Lead the annual organizational review and individual development program.</li></ul> Key Stakeholders: Internal: <ul><li>Site Leadership Team (Operations, Quality, Engineering, Warehouse, Finance, EHS)</li><li>Corporate HR</li><li>Manufacturing and Technical Services Teams</li><li>Validation and Project Management Teams</li></ul> External: <ul><li>FDA and other regulatory agencies</li><li>Third-party auditors and certifying bodies</li><li>External HR service providers</li><li>Customers and business partners</li></ul> Requirements: <ul><li>Bachelor’s degree in human resources, Business Administration, or related field (Master’s or HR certification preferred).</li><li>Minimum 5–10 years of progressive HR experience, including at least 3 years in a manufacturing or GMP-regulated environment and 3 years on site leadership team (pharma, biotech, or medical device strongly preferred).</li><li>Experience supporting high-growth or startup operations is highly desirable.</li></ul> Skills / Competencies: <ul><li>Strong understanding of HR compliance, labor laws, and best practices.</li><li>Demonstrated ability to build HR systems, processes, and policies from the ground up.</li><li>Demonstrated ability to improve HR systems and drive improved engagement and performance.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: Data Entry &amp; Maintenance <ul><li>Prepares crystal reports</li><li>Creates or approves static data entries</li><li>Adds/modifies calculations, workflows, and schemas as necessary</li></ul> Configuration/Customization <ul><li>Codes LIMS system to customize software platform</li><li>Integrates and customizes software with laboratory instrumentation</li><li>Responsible for instrument integration</li><li>Builds Crystal Reports</li><li>Assess change controls as they pertain to LIMS requirements.</li><li>Builds/Configure Electronic Laboratory Notebooks</li></ul> New Phases <ul><li>Participate in cross-site implementation of new LIMS features and enhancements</li><li>Coordinates roll-out of additional LIMS phases</li><li>Assists in Project Planning and Budget Spending</li></ul> Audit&nbsp; <ul><li>Performs periodic audits on the system, collates and presents the results of the audit to senior management, as required</li></ul> Training&nbsp; <ul><li>Develop training modules and provide user training as necessary</li></ul> End-User Satisfaction&nbsp; <ul><li>Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary</li></ul> Collaboration&nbsp; <ul><li>Interface with IT department on global LIMS issues</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li></ul> Other <ul><li>Performs other LIMS-related responsibilities as required by management</li></ul> Requirements: Qualifications&nbsp;Education &amp; Experience <ul><li>Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory</li><li>3+ years’ experience within software development</li><li>Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of 21 CFR Part 11</li><li>Strong knowledge of Computer System Validation techniques and practices</li><li>Company SOPs applicable to job</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>Strong understanding of Company SOPs applicable to job</li><li>GMP Knowledge of FDA regulations, primarily GMP regulations</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Advanced computer skills <ul><li>Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines</li><li>Strong interpersonal and communication skills; confident presenter, clear, concise technical writer. Able to interact with various departments and levels</li><li>Customer focused</li><li>Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions</li></ul> Physical Requirements <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Ability to lift 15 lbs.</li><li>Ability to walk across plant/laboratory</li><li>Travel up to 20% of the time may be required</li></ul>

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13 gmp Jobs found

Procurement Operations Manager

Quality Associate I

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

QC Chemist

Microbiology Technician

HR Manager

Manager – ADL GMP

Manager, Operations

Senior Quality Specialist, LIMS Administration

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13 gmp Jobs found

Procurement Operations Manager

Quality Associate I

Senior Quality & Reliability Engineer

Environmental Health and Safety (EHS) Manager

QC Chemist

Microbiology Technician

HR Manager

Manager – ADL GMP

Manager, Operations

Senior Quality Specialist, LIMS Administration

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