Quality Engineer

Reference Standard Coordinator

Staff Engineer - AI/ML

Director, Engineering Services

Manufacturing and Process Development Engineer

Senior Software QA - WMS

iOS - Sr/Staff Software Engineer

Senior Staff Software Engineer iOS

Halal Executive Chef

QC Chemist I

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</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 validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>As a Staff Engineer, you will play a pivotal role in shaping the future of Gen AI at our client by defining technical strategy, overseeing complex machine learning architectures, and ensuring seamless integration of Gen AI solutions into our platform and applications at scale.</li><li>You will mentor and guide a small engineering team while providing expertise in state-of-the-art AI/ML practices, ensuring a robust production pipeline and the professional management of models.&nbsp;</li></ul> Responsibilities: <ul><li>Help lead the technical strategy and execution for AI projects across the organization.</li><li>Designing, deploying, and managing the lifecycle of AI/ML models, including retraining and monitoring for continuous improvement within our solution.</li><li>Designing and driving Gen AI features on peta-byte scale datasets Driving innovation in NLP and other ML solutions, ensuring alignment with our client business goals. Architecting, developing and overseeing scalable, production-ready AI systems.</li><li>Providing technical mentorship to the AI/ML engineering team, fostering growth and collaboration.</li><li>Conducting in-depth research and staying abreast of advancements in Gen AI and deep learning technologies.</li><li>Collaborating with cross-functional teams, including Product, to evaluate business requirements and determine optimal AI solutions.</li><li>Reviewing code, offering best practices, and ensuring the delivery of high-quality solutions.&nbsp;</li><li>Representing our client technical excellence through publications, presentations, and participation in industry events.</li><li>Opportunity to work on cutting-edge AI projects at scale.</li></ul> Requirements: <ul><li>8+ years experience in managing large-scale datasets and distributed computing environments, with a preference for Google Cloud Platform expertise.</li><li>Java programming experience.</li><li>Experience with integration and deployment of AI/ML into production at scale within a SaaS solution.</li><li>Demonstrates independent thinking, capable of analyzing unique challenges, overcoming technical hurdles and delivering impactful AI solutions.</li><li>Hands-on experience with Generative AI techniques, including RAG pipelines, LLM fine-tuning, prompt engineering, and diffusion models.</li><li>Strong knowledge of generative AI frameworks and tools, such as Hugging Face, LangChain, or OpenAI APIs.</li><li>Experience in developing and scaling Generative AI solutions for NLP, vision, or multimodal tasks.</li><li>Advanced knowledge of modern AI frameworks, such as PyTorch, TensorFlow/Keras, Hugging Face Transformers, and JAX/Flax.</li><li>Expertise in Python, Docker, Kubernetes, and Helm.</li><li>Excellent communication skills, particularly in mentoring, knowledge sharing, and cross-team collaboration.</li><li>Willingness to be in office 3 days per week.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself 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>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>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Responsibilities: <ul><li>Participate in PRD (Product Requirements Document) review as early involvement activity.</li><li>To liaise with sales and product manager on product requirements for sustainability products.</li><li>To liaise with project engineer on manufacturing process for product mechanical design concept.</li><li>Knowledge in product structure, capabilities to create or establish product drawing using Creo 10, generate bill of materials and upload into company system.</li><li>Participate in product DFM review.</li><li>Participate in reviewing DFMEA, PFMEA and product design concept.</li><li>Challenge Product Design for Manufacturability and cost feasibility.</li></ul> Requirements: <ul><li>Bachelor or above degree and engineering background&nbsp;</li><li>3+ yrs. in assembly process development or product design/development experience</li><li>Good teamwork and communication skills&nbsp;</li><li>Skillful in using Creo 10</li><li>Knowledgeable of quality control and quality issue analysis and improvement.</li></ul>

Responsibilities: <ul><li>Design test plans, scenarios, scripts, or procedures.</li><li>Execute and oversee the execution of complex test cases.</li><li>Ensure effective test coverage across various components and integration points.</li><li>Take a lead role in defect management, including analysis, prioritization, and resolution.</li><li>Conduct root cause analysis for critical defects.</li><li>Collaborate effectively with development teams and other stakeholders.</li><li>Document software defects, using a bug tracking system, and report defects to software developers.</li><li>Identify, analyze, and document problems with program function, output, online screen, or content.</li><li>Test system modifications to prepare for implementation.</li><li>Provide feedback and recommendations to developers on software usability and functionality.</li><li>Monitor program performance to ensure efficient and problem-free operations.</li><li>Investigate customer problems referred by technical support.</li><li>Perform initial debugging procedures by reviewing configuration files, logs, or code pieces to determine breakdown source.</li><li>Stay informed about emerging trends, tools, and technologies in the field of quality assurance.</li></ul> Requirements: <ul><li>Knowledge and Testing experience on any one of the market WMS like Softeon WMS, Manhattan WMS, JDA/Blue yonder is a must.</li><li>Minimum 7 to 10 years of Testing experience</li><li>Experience in both Web and client/Server Testing</li><li>Experience in Automation Testing Tools primarily UiPath is preferred</li><li>Experience working on Agile Development Methodology&nbsp;</li><li>Self-Motivated Learner</li><li>Excellent written and verbal communication skills.</li><li>Bachelors degree and/or master’s degree in computer science or related discipline or the equivalent in education and work experience</li></ul>

The Role:&nbsp; <ul><li>As a iOS Engineer on our Consumer Credit Mobile team, you will be building and enhancing the Buy Now Pay Later or Credit Card products. </li><li>You will leverage your technical expertise to build solutions that empower our customers to effortlessly access and manage credit accounts. </li><li>You will build out scalable solutions, seamless experiences in partnership with other consumer credit engineering, product and UED teams.&nbsp;</li></ul> Responsibilities: <ul><li>Develop and maintain high performing, reusable Swift code and stay current with the newest mobile technologies.&nbsp;</li><li>Provide and receive feedback on code through pull requests and regular reviews of processes.&nbsp;</li><li>Work with product owners to crystallize the technical needs during grooming and planning&nbsp;</li><li>meetings. You will also work with engineering managers, engineers, and partner teams to&nbsp;</li><li>develop innovative solutions.&nbsp;</li><li>Define and develop processes, tools and methodologies to achieve excellence in software&nbsp;</li><li>development, testing, and deployment, follow coding standards and guidelines with attention to performance, scalability, and availability.&nbsp;</li></ul> Requirements: <ul><li>At least 5+ years of iOS development experience with Swift programming skills.&nbsp;</li><li>Understanding of mobile UI design principles, patterns, and best practices.&nbsp;</li><li>Experience building iOS applications connected to APIs – RESTful and GraphQL.&nbsp;</li><li>Practical knowledge of iOS architecture.&nbsp;</li><li>Experience with a version control system and the processes that come with committing, reviewing, and merging code across a team.&nbsp;</li></ul> Basic Qualifications:&nbsp; <ul><li>A solid grounding in Computer Science &amp; UI Design fundamentals.&nbsp;</li><li>2-3 years of experience building successful production software systems&nbsp;</li></ul>

Job Description:What you need to know about the role:As a iOS Engineer on our Consumer Credit Mobile team, you will be building and enhancing the Buy Now Pay Later or Credit Card products. You will leverage your technical expertise to build solutions that empower our customers to effortlessly access and manage credit accounts. You will build out scalable solutions, seamless experiences in partnership with other consumer credit engineering, product and UED teams.Meet our TeamJoining the Consumer Credit experience engineering team, you will get to showcase your work every day in the real world. With rapid success in the market, we are working both on consistently releasing new and improved features grounded in data-driven decisions as well as improving and iterating on current processes. The Consumer Credit team builds and maintains the product suite of Buy Now Pay Later and Credit Card products offerings for customers. Credit Card Mobile team develops and manages the end-to-end mobile experiences around Company's revolving consumer credit products in the United States and foreign markets.Your way to impact: You will build and contribute to high-performing systems in close partnerships with various teams. You will also possess keen judgment in selecting technologies and building the right solution for the meaningful challenges we get to tackle here. Responsibilities:Develop and maintain high performing, reusable Swift code and stay current with the newest mobile technologies. Provide and receive feedback on code through pull requests and regular reviews of processes. Work with product owners to crystallize the technical needs during grooming and planning meetings. You will also work with engineering managers, engineers, and partner teams to develop innovative solutions. Define and develop processes, tools and methodologies to achieve excellence in software development, testing, and deployment, follow coding standards and guidelines with attention to performance, scalability, and availability.  Requirements:At least 5+ years of iOS development experience with Swift programming skills. Understanding of mobile UI design principles, patterns, and best practices. Experience building iOS applications connected to APIs – RESTful and GraphQL. Practical knowledge of iOS architecture. Experience with a version control system and the processes that come with committing, reviewing, and merging code across a team. Basic Qualifications: A solid grounding in Computer Science & UI Design fundamentals. 2-3 years of experience building successful production software systems 

Role Description:We’re looking for motivated, engaged people to help make everyone’s journeys better.Reporting to the General Manager of the unit, the Executive Chef, Operations is responsible for daily monitoring of the preparation of the pre-designed meals for multiple customer accounts with culinary expertise through the management of all Chefs, Sous Chefs and Cooks at the unit, and promoting and providing quality food services to airline clients.Responsibilities:Achieves culinary operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; serving as culinary resource to operations managers; identifying and resolving problems; completing audits; determining system improvements; implementing change.Meets culinary financial objectives by estimating requirements; assisting with menu design; anticipating and evaluating response to menu presentation; scheduling expenditures; analyzing variances; initiating corrective actions; evaluating time-saving production techniques; training others in specialty techniques.Adheres to recipes and portion specifications as required by the customer by understanding consumer tastes and nutritional needs; reviewing product specifications; evaluating ease of menu preparation; applying established procedures and budgetary constraints.Oversees food preparation by consulting with the Buyer; Sous chefs, cooks, and team leaders; overseeing portion size; controlling productivity; providing culinary leadership in areas of personal expertise; monitoring presentations, garnishments, and sauces.Improves menu quality and consistency by analyzing food production records and menu expenses; promoting kitchen staff interest in quality improvement; studying, evaluating, and re-designing processes; implementing changes.Prepares menu and food preparation reports by collecting, analyzing, and summarizing food, dining, and customer data and trends.Maintains safe, secure, and healthy work environment by establishing, following, and enforcing standards and procedures; complying with sanitation and federal, state, and local legal regulations; overseeing food preparation, safety, and security; reviewing and implementing accident and disaster plans.Using menu specifications, maintains food ingredients, food preparation, and general supplies by selecting and purchasing menu ingredients; evaluating the quality of fresh food and food product deliveries; maintaining general supplies; establishing inventory levels, re-order points, storage requirements, and cost-controls.Maintains culinary equipment by following operating instructions; instructing staff in equipment use; troubleshooting breakdowns; maintaining equipment supplies; performing preventive maintenance; calling for repairs; evaluating new equipment; preparing administrative proposals to justify purchases.Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; being sought for opinions as a culinary expert; contributing to professional publications; participating in professional societies and sharing this information with direct reports.Accomplishes culinary goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.Ensures quality production standards are followed and maintained. Ensures employees adhere to HACCP, FDA and safety regulations and compliance with company policies and procedures.Trains and monitors employees on proper work procedures and production of products to ensure maximum productivity with minimum labor and food expenses.Assists in the development and training of cooks as required.Prepares administrative reports as required.Ensures maximum productivity and labor costs are maintained according to financial requirements. Monitors daily manpower planning and employee turnover. Responsible for employee retention.Ensures meal cycles are communicated in a timely and accurate basis. Monitor yields of products to ensure maximum usage.Works with management staff to improve performance of the unit.Ensures Menu presentations are properly planned, set up, and specifications reviewed to ensure compliance.Maintains labor requirements, food costs, overtime, and all productivity requirements.Must ensure all cooks, and Sous Chef employees have the skill and ability to perform all cooking and food preparation requirements of all the Airline Accounts serviced in the Unit.Ensures all products are cooked at required temperature according to airline and food safety specification, etc.Responsible for coaching, counseling and preparing corrective action for employees.Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.Requirements:Education:Associate Degree or Bachelor Degree in the Culinary Arts or a related field, (formal culinary education) required or at least 4 years of experience in an Executive Chef role.Work Experience:Minimum 10 years of experience as a Chef required.Minimum of 4 years of experience as an Executive Chef required.Minimum of 1-3 years of supervisory experience working in a high volume, manufacturing, food production, and restaurant or catering environment required.In-flight catering experience or experience in a high-volume food service environment required.Halal: 5 years of experience required.ServSafe Certified preferred.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.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.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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11 reviewing Jobs found

Quality Engineer

Reference Standard Coordinator

Staff Engineer - AI/ML

Director, Engineering Services

Manufacturing and Process Development Engineer

Senior Software QA - WMS

iOS - Sr/Staff Software Engineer

Senior Staff Software Engineer iOS

Halal Executive Chef

QC Chemist I

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11 reviewing Jobs found

Quality Engineer

Reference Standard Coordinator

Staff Engineer - AI/ML

Director, Engineering Services

Manufacturing and Process Development Engineer

Senior Software QA - WMS

iOS - Sr/Staff Software Engineer

Senior Staff Software Engineer iOS

Halal Executive Chef

QC Chemist I

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