Assistant R&D Manager

Senior Data Scientist II

Manufacturing Engineer II

Lab Manager

Senior Product Development Engineer

Sr. Mechanical Engineer

MGR II Laboratory

Quality Control Supervisor

Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

Purpose of the role: <ul><li>Create new and improve existing foods and processes by applying technical, food science and culinary skills in cereals through complex formulas, processing procedures and specifications for new products, product enhancements, and cost reductions to meet project needs in a constantly evolving business environment.</li><li>Capable of working at a fast and agile pace on multiple projects simultaneously, whilst interacting successfully with internal and external stakeholders.</li></ul> Responsibilities: <ul><li>Key contributor within the experienced R&amp;D team supporting all development and commercialization aspects (including Food &amp; Packaging) of new product introductions, as well as productivity and quality improvements of existing products.</li><li>Develop experimental formulas, processing procedures, and specifications for raw ingredients, subassemblies, and finished products for simple new product, product improvement, and cost optimization by applying technical, food science and culinary skills and by interpreting consumer and customer needs and assembling input from cross-functional teams. Effective collaboration and communication cross functionally.</li><li>Evaluate ingredients and processing techniques to identify and commercialize product improvement and cost optimization opportunities.</li><li>Prepare prototype products to the design brief and present to the business through leading effective food reviews.</li><li>Design, plan and execute experiments for bench top, pilot plant and plant trials, gather and analyze data, document and report results, and make recommendations.</li><li>Ensure successful start-ups of new products, product improvements, cost reductions, and ingredient, formula, specification, or process changes from product concept development, formulation design, prototype development, cost calculation, specifications, quality assessment, legislation compliance checks and claim assessments.</li><li>Document all work according to guidelines and provide timely project reports to ensure good communication of project status, progress, issues and timeline.</li><li>Support labeling, nutritional, regulatory, quality and food safety efforts.</li><li>Create Nutritional Label Information.</li><li>Actively research for opportunities, trends, consumer insights and competitor landscape.</li><li>Develop and maintain understanding of local/regional regulations &amp; legal requirements and their standards. Develop claims and products at EU level, ensure approval for each launch country with regional Regulatory Affairs &amp; Legal functions.</li></ul> Requirements: Knowledge: <ul><li>Bachelor’s degree in food science, Food Engineering, Chemistry or related fields desirable.</li></ul> Experience: <ul><li>1-3 + years of industrial experience in the food industry.</li></ul> Skills and Abilities: <ul><li>Knowledge and experience with ingredient functionality, product design and formulation, and commercialization</li><li>Solid knowledge and understanding of food chemistry, food processing, and food functionality.</li><li>Strong technical and project management skills with results orientation</li><li>Excellent written and verbal communication skills; able to effectively communicate to all levels within the organization.</li><li>Professional working proficiency in English (Reading, Writing and Speaking).</li><li>Ability to collaborate cross-functionally, building strong relationships across R&amp;D, Marketing, Finance, Procurement, Quality, Manufacturing, Planning and External Stakeholders.</li><li>Ability to effectively influence others and get results through working with a diverse team, and to continuously challenge assumptions to seek innovative solutions.</li><li>Demonstrated ability to prioritize and manage complexity.</li><li>Executional excellence, personal leadership, time management, organization, and problem solving competencies.</li><li>Ability to be flexible and adaptable to move with a changing environment.</li><li>Ability to define problems, collect data, establish facts, draw valid conclusions, and offer solutions.</li><li>Ability to thrive in a face-moving, dynamic, team environment that encompasses end-to-end development (concept and exploration through manufacturing scale up, start up and process optimization).</li><li>Passion for food and the environment</li><li>Ability to work flexibly when required. Interstate and overseas travel may be required</li></ul>

About the Role : <ul><li>As a data scientist on our team, you will work on new product development in a small team environment writing production code in both run-time and build-time environments.&nbsp;</li><li>You will help propose and build data-driven solutions for high-value customer problems by discovering, extracting, and modeling knowledge from large-scale natural language datasets including matter and contract repository, invoice/legal spend data and work management.&nbsp;</li><li>You will prototype new ideas, collaborating with other data scientists as well as product designers, data engineers, front-end developers, and a team of expert legal data annotators.</li><li>You will get the experience of working in a start-up culture with the large datasets and many other resources of an established company.</li><li>We are committed to advancing gender diversity within the technology sector and supporting greater representation of women in tech. To further this commitment,</li></ul> Responsibilities: <ul><li>Develop and implement LLM-based applications tailored for legal use-cases&nbsp;</li><li>Evaluate and help maintain our data assets and training/evaluation data sets&nbsp;</li><li>Design and build pipelines for preprocessing, annotating, and managing legal document datasets&nbsp;</li><li>Collaborate with legal experts to understand requirements and ensure ML-applications meet domain-specific needs&nbsp;</li><li>Conduct experiments and evaluate model performance to drive continuous improvements&nbsp;</li><li>Fine-tune and deploy large language models to enhance their performance on legal text processing tasks&nbsp;</li><li>Interface with other technical personnel or team members to finalize requirements.&nbsp;</li><li>Work closely with other development team members to understand complex product requirements and translate them into software designs.&nbsp;</li><li>Successfully implement development processes, coding best practices, and code reviews for production environments.</li></ul> Requirements:&nbsp; <ul><li>Able to work in person 2 days per week&nbsp;</li><li>Bilingual English and Spanish&nbsp;</li><li>Practical experience with large language models, prompt engineering, fine-tuning RAG-based applications and benchmarking, using frameworks such as LangChain&nbsp;</li><li>MS in Data Science, Computer Science, Statistics, Machine Learning, or relevant work experience&nbsp;</li><li>Practical experience in Natural Language Processing methods and libraries such as spaCy, word2vec, Flair, BERT (ways to vectorize text data)&nbsp;</li><li>Formal training in machine learning: dimensionality reduction, clustering, embeddings, and sequence classification algorithms&nbsp;</li><li>Strong Python background&nbsp;</li><li>Knowledge of AWS, GCP, Azure, or other cloud platform&nbsp;</li><li>Understanding of data modeling principles and complex data models.&nbsp;</li><li>Proficiency with relational and NoSQL databases as well as vector stores (e.g., MySQL, Postgres, Solr, Elasticsearch/OpenSearch)</li><li>Knowledge of Spark-Scala, Ray or other distributed computing systems highly preferred&nbsp;</li><li>Knowledge of API development, containerization, and machine learning deployment highly preferred&nbsp;</li><li>Experience with ML Ops/AI Ops including experiment tracking tools like LangFuse and DVC&nbsp;</li><li>Experience with deep learning frameworks such as PyTorch, Tensorflow and Hugging Face Transformers Work in a way that works for you We promote a healthy work/life balance across the organization. </li><li>We offer an appealing working prospect for our people.&nbsp;</li><li>With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate. </li><li>Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive.</li></ul>

Responsibilities: <ul><li>Analyze and improve all existing equipment, processes, and designs as required</li><li>Create manufacturing documentation to support existing processes and equipment in accordance with ISO 9001 requirements</li><li>Train the engineering technicians and other manufacturing personnel on the production floor on new processes or equipment.</li><li>Design and implement processes, equipment, and documentation for all new projects</li><li>Design small fixtures and tooling</li><li>Participate in cost reduction and cost of quality programs</li><li>Assist maintenance in troubleshooting and repair of equipment</li><li>Assist Design Engineering with prototyping of new or modified products</li><li>Support production and development of new products through independent review, root cause analysis, corrective action, discrepancy handling, and defect prevention</li><li>Conduct process capability studies, design experiments, conduct studies and analyze to ensure products meet requirements</li></ul> Requirements: <ul><li>Personal computer skills such as MICROSOFT OFFICE and relational database.</li><li>Excellent communication skills</li><li>Ability to work well in a Team environment</li><li>Effectively present information and respond to questions from groups</li><li>Ability to work under direct supervision</li><li>Ability to work with clearly defined project steps</li><li>Possess some limited knowledge of new product development processes and work flow</li><li>Possess a working knowledge of some SBU product lines</li><li>Experience in participating on multi-disciplinary product development teams</li><li>Basic knowledge of a particular technical area</li><li>Bachelor’s degree in an engineering field.</li><li>2-5 years of experience</li></ul>

Responsibilities: Primary Duties: <ul><li>Coordinate scheduling of resources and tests to maximize lab utilization while meeting project deadlines and communicating them to (primarily internal) customers.</li><li>Lead and mentor a team of technicians and engineers, providing guidance, training, and support as needed.</li><li>Manage inventory of high voltage testing equipment, including procurement, maintenance, and retirement planning.</li><li>Ensure compliance with safety standards and regulations, implementing necessary policies and procedures to maintain a safe working environment.</li><li>Ensure compliance with audits such as ISO 17025.</li><li>Monitor project progress, identify potential issues, and implement solutions to ensure successful project completion.</li><li>Foster a collaborative and productive work environment, promoting teamwork and professional development.</li><li>Conduct performance evaluations and provide feedback to team members to drive continuous improvement.</li><li>Implement quality control measures to ensure accuracy, reliability, and consistency of test results.</li><li>Review test data and reports to verify compliance with project requirements and specifications.</li><li>Continuously assess and improve testing procedures and methodologies to enhance efficiency and effectiveness.</li><li>Evaluate new technologies and equipment upgrades, recommending investments to enhance lab capabilities.</li></ul> Requirements: What Your Background Should Look Like: <ul><li>Bachelor’s degree in Electrical Engineering, Physics, or a related field; Master’s degree preferred.</li><li>8+ years’ experience with minimum 2+ years in high voltage testing 35kV+, and should have 2+ years’ in leadership role - preferably in an industrial or research setting; and laboratory experience required.</li><li>Proven project management abilities, including the ability to prioritize tasks, allocate resources, and meet deadlines.</li><li>Excellent leadership and communication skills, with the ability to effectively manage teams and collaborate with diverse stakeholders.</li><li>Understanding of electrical engineering principles, particularly in the areas of high voltage systems and insulation testing.</li><li>Familiarity with relevant standards and regulations, such as IEEE, IEC, ANSI, and NFPA.</li><li>Attention to detail and a commitment to quality, with the ability to troubleshoot problems and implement solutions in a timely manner.</li></ul>

Responsibilities: <ul><li>Monitors the external market and is a key supporting team member in the development of disruptive products to enhance the Company’s product offering.</li><li>Maintains communication with technical staff and field operations to be proactive in identifying performance and failure trends.</li><li>Identifies opportunities for technological improvements/modifications to the Company’s product line and submits recommendations for sustainable engineering projects and new R&amp;D projects</li><li>Performs complex design and drafting of new and existing parts/assemblies.</li><li>Prepares, checks, and maintains engineering documentation.</li><li>Performs advanced engineering calculations and simulations.</li><li>Leads Engineering projects by conducting tests/experiments, collecting information, and analyzing results.</li><li>Provides technical input related to products and performance, both internally and externally.</li><li>Works effectively with vendors from initial prototype manufacturability studies to mature product support and optimization</li><li>Serve as mentor to more junior engineers to ensure all Engineering tasks are completed in accordance with established organizational processes and Engineering requirements</li><li>Supports and collaborates with other departments within the organization.</li></ul> Requirements: Minimum Qualifications: <ul><li>B.S. in Mechanical Engineering or related four-year degree.</li><li>7+ years of experience as a mechanical engineer with relevant mechanical design experience.</li><li>Eligible to drive Company or personal vehicle for Company purposes including the ability to meet requirements of the Company’s Vehicle Use Agreement and Driving.</li></ul> Policy Preferred Qualifications: <ul><li>Experience with SolidWorks and SolidWorks Simulation, or similar programs.</li><li>Proven track record of innovative design solutions and problem-solving skills.</li><li>Proficient in CAD/FEA software.</li><li>Strong computer skills with ability to utilize discipline specific-software applications to drive efficiency in productivity</li><li>Must be self-motivated, with the ability to oversee and motivate others and influence decisions, capable of identifying problems and recommending alternative solutions</li><li>Must be a self-starter able to take initiative, make decisions and drive for results.</li><li>Must demonstrate a high level of professional integrity and demeanor.</li><li>Strong written and oral communication skills with demonstrated ability to conduct effective presentations and written report preparation.</li><li>Able to effectively make technical decisions and manage change requests.</li><li>Ability to manage time effectively, think strategically and translate concepts into action plans and track results.</li><li>Ability to build engaging relationships at all levels of the organization as well as with customers.</li><li>Ability to work independently as well as part of a team, managing multiple tasks and projects simultaneously to meet challenging deadlines.</li><li>Experience leading projects and performing increased job responsibilities over time.</li></ul>

Responsibilities: Detailed Description: <ul><li>Monitors the external market and is a key supporting team member in the development of disruptive products to enhance the Company’s product offering</li><li>Maintains communication with technical staff and field operations to be proactive in identifying performance and failure trends</li><li>Identifies opportunities for technological improvements/modifications to the Company’s product line and submits recommendations for sustainable engineering projects and new R&amp;D projects</li><li>Performs design and drafting of new and existing parts/assemblies</li><li>Prepares, checks, and maintains engineering documentation</li><li>Performs engineering calculations and simulations</li><li>Participates in R&amp;D projects by conducting tests/experiments, collecting information, and analyzing results</li><li>Provides technical input related to products and performance, both internally and externally</li><li>Supports and collaborates with other departments within the organization Job</li></ul> Requirements: Minimum Qualifications: <ul><li>B.S. in Mechanical Engineering or related four-year degree</li><li>5+ years of experience as a mechanical engineer</li><li>Eligible to drive Company or personal vehicle for Company purposes including the ability to meet requirements of the Company’s Vehicle Use Agreement and Driving</li></ul> Policy Preferred Qualifications: <ul><li>Experience with SolidWorks and SolidWorks Simulation, or similar programs</li><li>3D CAD design experience.</li><li>Proven track record of innovative design solutions and problem-solving skills</li><li>Knowledge of CAD/FEA software</li><li>Strong computer skills with ability to utilize Microsoft Office Software and other discipline specific-software applications to drive efficiency in productivity</li><li>Must be self-motivated, with the ability to oversee and motivate others and influence decisions, capable of identifying problems and recommending alternative solutions</li><li>Must be a self-starter able to take initiative, make decisions and drive for results.</li><li>Must demonstrate a high level of professional integrity and demeanor</li><li>Strong written and oral communication skills with demonstrated ability to conduct effective presentations and written report preparation</li><li>Able to effectively make technical decisions and manage change requests</li><li>Ability to manage time effectively, think strategically and translate concepts into action plans and track results</li><li>Ability to build engaging relationships at all levels of the organization as well as with customers</li><li>Ability to work independently as well as part of a team, managing multiple tasks and projects simultaneously to meet challenging deadlines</li><li>Experience leading projects and performing increased job responsibilities over time.</li></ul>

Responsibilities: Undertake overall Responsibility:&nbsp; <ul><li>Manage in FA function and leading modern technology to coordinating with engineering to develop core Tech and able to expand to lab levels for daily delegated tasks to manage the related database consolidation.&nbsp;</li><li>Driving with company OA improvement on process or capability improvement to make lab goals achieved and support engineering to win in markets.&nbsp;</li></ul> Responsible for Strategy:&nbsp;&nbsp; <ul><li>Set clear FA direction goals and develop strategies with high-level visions that reframes what winning looks like and approaches to fulfil modern technology assignments in creative and meaningful ways.</li><li>Providing strategy for FA/Lab directions align with organization value drivers and tactics to key program execution with excellence and flexible. </li><li>Such as Identify FA team with right size, people skills and address technical assistance to design feasibility and make recommendations for necessary changes.</li><li>Transform stakeholders need and assess FA/Lab capability tried-and-true options for scenarios allocate resources to high priorities (people, cost $, management attention, sustainability etc) to significantly shorten the product design cycle and help bring products to market faster while ensuring high quality and performance. </li><li>also sorts of possibilities to creating an optimal flow to shaping up team to be more engaging and easier to follow.</li><li>With financial knowledges to assess capability and predict organization forecast and analysis per budget scope, and build long-term constructive common ground network across the adjacent functions such as Product Engineering, Project Engineering and Field Application Engineering etc.&nbsp;</li><li>Align organization culture targeting and systematically pursuing specific areas for further secure lab competitiveness, i.e. (Software/ System/CoE/ 3DP/New Tech etc)&nbsp;</li></ul> Responsible for lab strategy mobilization and execution: <ul><li>Communicate and distribute the requirements per lab programs implementation keeps FA/Lab ahead of or at pace with the competition,</li><li>Boost and Outline the necessary investment plan of amount, relevance and quality of test equipment in FA/lab, driving efficiency to maximize value and return on investment.</li><li>Create and use systems for monitoring and manage various performance in FA function OKR/KPIs to process control and follow up and streamline the process and balance of stability and agility that maximizes the speed and effectiveness by using digital data-driven techniques, show diagram visually.</li><li>Broad knowledge to develop FA/Test/3DP etc method per core technology to foster FA/lab growing, and design new correction/prevention quality initiatives to pinpoint the risks and minimize lab operation obstacles, build resilience ahead of any potential crises and update risk assessments so that enable lab able to mitigate the impact and unlock opportunities.</li><li>Define FA/Lab operation mechanism, criteria, and management discipline to ensure FA/Lab for daily work what is in good working order.</li><li>Leading Team use data to make timely decisions.&nbsp;</li><li>Research new development method and set guidelines enables engineering/manufacturers to better process control and maintain quality within acceptable limits to prevent failure in early stage, approaching smart tech to accelerate the testing,inspection and analysis activities,&nbsp;</li></ul> Succession Talent Effectiveness:&nbsp; <ul><li>Identify key talents per OLR and drive team and equip team development goals to ensure most value-creating roles in lab filled with right position.</li><li>Capable with management skills to prepare effective office support in place, such as Give Training and properly communicate findings so as to help team to continuously improving their abilities to ensure lab organization successfully and sustainable as whole team can do or to achieving next level."</li></ul> Requirements: <ul><li>Master’s degree or above level of qualification in Engineering technology areas</li><li>Minimum 8+years of similar industry Engineering field and for management, English listening, speaking, writing ability are required.</li><li>Experience in technical technology on validation test, Failure Analysis, or 3D printing, tool application or system Engineering preferred.</li><li>Proactive oriented and tenacity to results driven.</li><li>practitioner well on logic and structure skills</li><li>Manager level experiences with ISO/IEC 17025 lab system standards and engineering skills</li><li>Demonstrated ability in conducting audits and all aspects of communication, collaboration and team building skills.</li><li>Proficient ability in developed the new tech to reduce redundant testing or inspection activities, or experience for new program/project boosting and launch preferred.</li><li>Outstanding engineering background and Test field for now organization management and with software capabilities would prefer.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <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>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</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><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: Product Testing: <ul><li>Demonstrate expert-level knowledge in fiber optic component and assembly testing.</li><li>Develop and optimize test specifications and methodologies for optical components and assemblies.</li><li>Design and implement complex tests using state-of-the-art equipment.</li><li>Create, review and estimate fiber optic test plans.</li><li>Lead the development of new sample preparation techniques and testing procedures, creating comprehensive documentation and training materials for the team.</li><li>Perform in-depth data analysis and interpretation, identifying trends, potential failures, and opportunities for product improvement.</li><li>Collaborate with cross-functional teams, including product development, quality assurance, and manufacturing, to ensure seamless integration of test results into the product lifecycle.</li><li>Lead multiple high-priority projects simultaneously.</li><li>Manage timelines, resources, and deliverables for various testing initiatives.</li><li>Maintain a safe, orderly, and efficient work environment in both office and laboratory areas, setting the standard for workplace organization and safety compliance.</li><li>Report project status to key stakeholders.</li><li>Drive innovation in test methodologies and equipment utilization.</li></ul> Lab Oversight: <ul><li>Oversee daily operations of the fiber optic test laboratory</li><li>Manage lab resources, including equipment, supplies, and budgets</li><li>Coordinate workload and assign projects to lab personnel</li><li>Ensure compliance with safety regulations and quality standards</li><li>Develop and implement lab policies and procedures</li><li>Participate in strategic planning for laboratory expansion and capability enhancement.</li><li>Identify opportunities for process improvement and cost reduction</li><li>Collaborate with other departments to align lab capabilities with company goals.</li></ul> Requirements: <ul><li>Bachelors or Master’s degree in Electrical Engineering, Optical Engineering, or related field</li><li>10+ years of progressive experience in fiber optic testing</li><li>Management or team lead experience a plus</li><li>Demonstrated expertise in fiber optic technologies and test methodologies</li><li>Strong background in data analysis, statistical methods, and test automation</li><li>Excellent leadership, communication, and interpersonal skills</li><li>Proven track record of technical leadership and project management</li><li>Experience in lab operations, resource management, and budgeting</li><li>Proficiency in MS Office Suite, test automation software, and data analysis tools</li><li>Adaptability to shifting priorities and ability to manage multiple projects</li></ul> Physical Demands: <ul><li>Must be able to lift up to 35 pounds without assistance</li><li>Capable of sitting for extended periods while performing detailed analytical work</li><li>Occasional standing, bending, and maneuvering in laboratory environments</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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17 lab experiments Jobs found

Assistant R&D Manager

Senior Data Scientist II

Manufacturing Engineer II

Lab Manager

Senior Product Development Engineer

Sr. Mechanical Engineer

MGR II Laboratory

Quality Control Supervisor

Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

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17 lab experiments Jobs found

Assistant R&D Manager

Senior Data Scientist II

Manufacturing Engineer II

Lab Manager

Senior Product Development Engineer

Sr. Mechanical Engineer

MGR II Laboratory

Quality Control Supervisor

Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

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