Process Engineer Technical Operation

QC Chemist I

Reliability Technician-Packaging

Office Manager & HR Generalist

QC Supervisor

Specialist, DEA Compliance

Supply Chain Manager

Associate I, Quality Operations

Validation Engineer

Laboratory Systems Analyst

Responsibilities:&nbsp; <ul><li>Perform Tech Transfer activities for CMO products with minimum guidelines specifically for liquid, powder filling, soft gel and semi solid that consist of designing, planning, conducting review of pre-formulation, formulation, and process development activities as well as scale-up trials.</li><li>Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.&nbsp;</li><li>Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.</li><li>Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.</li><li>Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.</li><li>Initiate change control for new products, site transfer products and changes related to the process improvement with appropriate justification.&nbsp;</li><li>Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.</li><li>Author and review investigation reports, protocols, batch records and CMC documentation.</li><li>Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects.</li><li>Lead and execute material changes, process changes and cost reduction projects.</li><li>Performs other related duties as assigned.</li><li>Provide technical training and assistance to others.</li></ul> Requirements: <ul><li>A Bachelor’s in Chemical Engineering preferred.</li><li>Experience with manufacturing liquid, cream, gel, powder filling, soft gel etc preferred.</li><li>Proficiency with statistics (using Minitab) preferred.</li><li>Experience using Excel for data mining and analysis is must.</li></ul>

Responsibilities: <ul><li>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.</li><li>May participate in investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.</li><li>Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>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.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>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><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.</li><li>May assist in drafting, editing, and reviewing SOPs and laboratory investigations.</li><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of less senior laboratory staff.</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances continuous.</li><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 continuous.</li></ul> Requirements: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job.</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.&nbsp;</li><li>Some pharmaceutical laboratory experience preferred.</li><li>Proficiency in a body of information required for the job.</li><li>e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>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.&nbsp;</li><li>Basic knowledge of wet chemistry techniques.</li><li>Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</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><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><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>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.&nbsp;</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>

Responsibilities: <ul><li>Develops and applies basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position. </li><li>Focused on a limited range of activities.&nbsp;</li><li>Completes routine tasks that are typically embedded in SOPs, operational or technical work practices and guidelines. Learns to identify deviations from accepted practice or procedure.</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.&nbsp;</li><li>Learns the responsibilities of being a team member. Participates as a team member. Collaborates primarily within the immediate work unit, which may be cross-functional.</li><li>Close supervision involving detailed instructions and requires regular checks on work performance.</li></ul> Requirements: <ul><li>HS diploma or equivalent with related certification, or HS diploma or equivalent with 2-4 years’ related experience.</li><li>Ability to use Blue Mountain for PM execution and utilization of Apple tablets to complete PMs and MSRs desired.&nbsp;</li><li>Ability to use and read test instruments.&nbsp;</li><li>Ability to learn pharmaceutical maintenance and cGMP processes.&nbsp;</li><li>Ability to learn to perform tasks and read basic schematics, technical drawings and/or blueprints.&nbsp;</li><li>Ability to learn set ups.&nbsp;</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.</li></ul> Knowledgeable in one or more of the following areas: <ul><li>Electrical</li><li>Hydraulic</li><li>Pneumatics</li><li>Mechanical</li><li>PLCs</li><li>Basic math, writing skills, and excellent problem solving abilities.&nbsp;</li><li>Basic computer skills.&nbsp;</li><li>Ability to use hand tools safely.&nbsp;</li></ul>

Overview: <ul><li>Coordinates and oversees administrative duties, ensures that U.S. offices operate efficiently and smoothly, and acts as face to the company.&nbsp;</li><li>Responsibilities include greeting visitors, managing office supplies, overseeing other administrative staff (as needed), owning office budgets, and supporting select staff with administrative tasks (i.e. Business President, HR, Sales &amp; Customer Operations).</li></ul> Responsibilities:&nbsp;&nbsp;&nbsp; <ul><li>Perform administrative duties in the office and ensure that office is operating smoothly&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Manage office supplies inventory, place orders and negotiate contracts as necessary&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Greet visitors (including but not limited to external officials, regulators, and executives)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Receive and sort incoming mail and deliveries, and manage outgoing mail&nbsp;</li><li>Develop office policies and procedures, and ensure they are implemented appropriately&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Assist with office layout planning and office moves, and coordinate with IT as needed&nbsp;&nbsp;</li><li>Manage office budget&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Identify opportunities for process and office management improvements&nbsp;&nbsp;</li><li>Provide administrative support as necessary, including scheduling group meetings, maintaining calendars, processing expense reports, doing research and creating reports&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Manage logistical support of visitors, such as company executives and business partners</li><li>Organize events including Trade Shows / Customer Event registration, booth coordination, travel arrangements and other activities as needed</li><li>Development and manage company activities, philanthropy projects and external communications to such organizations&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li><li>Manage departmental records: gathering information, tracking documents, creating, and maintaining traditional and electronic records and files&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Proficiency in a body of information required for the job&nbsp;&nbsp;</li><li>Bachelor’s Degree a plus and/or equivalent experience</li><li>Proficient in Microsoft Office</li><li>Scheduling meetings</li><li>Phone business etiquette</li><li>Arranging and tracking travel</li><li>Negotiating small contracts with office supply vendors and managing purchase orders</li></ul> Knowledge: <ul><li>Advanced skills in using spreadsheet, word-processing, power point application software.</li><li>Ability to effectively prepare written correspondence, presentations, answer and screen calls and plan/coordinate meetings.</li><li>Ability to communicate effectively with individuals and groups.</li><li>Ability to solve HR related problems by combining judgment with knowledge of business practices.</li><li>Ability to work independently and in teams. Demonstrated excellence in organizational and time-management skills with the ability to multi-task.</li><li>Ability to handle sensitive and confidential information.</li><li>Strong, professional interpersonal skills; experience establishing effective relationships with business leaders and external partners, while managing stressful situations.</li><li>Ability to solve problems, exercise judgment within generally defined practices and policies.</li><li>Detail oriented.</li></ul> Abilities &amp;Physical Requirements:&nbsp;&nbsp;&nbsp;&nbsp; <ul><li>Sit, Stand, Bend frequently.</li><li>Adapt to various environments including shop floor.</li><li>Lift 10 – 20 pounds.</li><li>Business travel &lt;5%.</li></ul>

Responsibilities: <ul><li>Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.</li><li>Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.&nbsp;&nbsp;</li></ul> Testing: <ul><li>Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.</li><li>Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.</li><li>Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.</li><li>Perform methods development, transfer, verification and validation activities.&nbsp;</li><li>Coordinate and assist with evaluation of Process Validations studies.&nbsp;&nbsp;&nbsp;</li></ul> Documentation Practice, Training and Compliance: <ul><li>Ensure work of staff is in compliance with good documentation practices per companys SOP and cGMP regulations in the laboratory.&nbsp;&nbsp;</li><li>Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.</li><li>Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.</li></ul> Lab Maintenance: <ul><li>Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.</li><li>Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.</li><li>Monitor ordering of lab supplies.</li><li>Enforce the control and management of controlled substances.&nbsp;&nbsp;</li></ul> Staff Development:&nbsp; <ul><li>Evaluate potential candidates for QC; prepare annual performance evals. for chemists.&nbsp;&nbsp;&nbsp;</li><li>Prepare chemists and laboratory for FDA and other compliance audits.</li><li>Ensures adequate resources are trained to support compliance and business initiatives.</li></ul> Requirements: Education &amp; Experience: <ul><li>BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.</li><li>7+ years of experience in pharmaceutical laboratory.</li><li>2+ year QC supervisory experience preferred.</li></ul> Knowledge: <ul><li>Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.</li></ul> Skills &amp; Abilities: <ul><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>Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.</li><li>Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.</li><li>Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.</li><li>Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.</li><li>Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.</li><li>Good verbal and written communications with basic computer skills.</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.&nbsp;</li><li>The work environment is representative of a group laboratory environment.&nbsp;</li></ul>

Role Description: <ul><li>The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.</li><li>Those matters include licenses, procurement, and movement of material, production, shipment and destruction.</li><li>Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.</li></ul> Responsibilities: <ul><li>DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at site</li><li>Reviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)</li><li>Maintains Know your Customer (KYC) information</li><li>Conducts year‐end and biennial inventory and report ARCOS quarterly reporting &amp; cycle count inventory via DEA website</li><li>Coordinates all movement of controlled substances from manufacturing through analytical testing</li><li>Liaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperwork</li><li>Maintains compliance of all DEA, State, and Board of Pharmacy registrations</li><li>Coordinates all controlled substance destruction with QC, Environmental, Health &amp; Safety and Logistic departments</li><li>Works with Security department to maintain facility upgrades to security systems</li><li>Power of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 forms</li><li>Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities</li><li>Coordinates and documents DEA audits for sites and issues audit reports to management upon completion</li><li>Remains current on DEA regs in order to address organization business needs</li><li>Creates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.</li></ul> SOPs: <ul><li>Updates associated SOP’s related to job functions</li></ul> Supporting responsibilities:&nbsp; <ul><li>Back up to State Licensing associate</li><li>Participates and represents department at project meetings as required</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor’s degree in a relevant field required</li><li>2+ years’ relevant work experience</li></ul> Experience with IQVIA SOM software preferred <ul><li>Working knowledge of GMP regulations and compliance issues</li><li>Strong knowledge of DEA and FDA regulations</li><li>Knowledgeable of production and production planning processes</li></ul>

Responsibilities: <ul><li>Responsibilities include assess supply chain status of products, planning/executing goods movements (production and inbound goods) also ensuring completeness and accuracy of SAP data.</li><li>Participate in the review/confirmation of the demand forecast; assess inventory level of all finished goods based on the demand forecast; oversee and/or validate inventory planning at the manufacturing sites.</li><li>Work closely with the 3PL to ensure timely receipt of shipments.</li><li>Mediate the resolution of any delays in having product available for sale</li><li>Prepare monthly inventory report, analyze and highlight projected inventory concerns based on Supply Plan.</li><li>Act as a contact for any planning/inventory availability issues with the plant manufacturing and supply team.</li><li>Provide oversight on all relevant product launch activities, and effectively manage internal and external stakeholders to ensure alignment on resource requirements.</li><li>Routinely collaborate with department head to achieve cross company alignment with respect to product supply risk and upside, inventory management through all downstream nodes Ensure continuity of supply for all products</li><li>Analyze and manage adequate inventory levels per guidelines, provide internal stake holders analysis of low and excess inventory items</li><li>Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items</li><li>Provide logistics support, as needed, including coordination and prioritization of planned shipments as well as shipment tracking</li><li>Inventory management and Logistics tracking including coordination with brokers for relevant deliveries.</li><li>Support data analysis for RFP’s – weekly, monthly and annual RFP’s.</li><li>Aid in analysis and review of 3 PL warehousing cost and other operational and logistical expenses.</li><li>Aid in process improvement mechanisms to enhance service level and inventory management.</li><li>Support serialization track and trace project.</li><li>Aid in process improvement mechanisms to enhance service and inventory.</li></ul> Requirements: Desired Skills: <ul><li>Highly analytical skills with strong problem solving ability utilizing minimal supervision</li><li>Excellent interpersonal skills ; team player ability to bridge strong working relationships across multiple disciplines</li><li>Ability to work in a global business culture</li><li>Excellent communication, verbal and written</li><li>Bachelor’s degree, preferably in supply chain, operations or related discipline.</li><li>Atleast 3 years of relevant experience in Supply Chain in pharmaceutical industry(preferred)</li><li>Demonstrated expertise with MS tools including Excel, Word, and Power Point. Expertise using SAP desirable.</li><li>Ability to manage large volume of spreadsheet data</li></ul>

Responsibilities: <ul><li>The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.</li><li>Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.</li><li>Communicates to multiple departments and supervision to provide timely process and issue updates.</li><li>Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.</li><li>Participates in reviews and structured processes for continuous improvement.&nbsp;&nbsp;</li></ul> Quality Operations: <ul><li>Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.</li><li>Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.</li><li>Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.</li><li>Follows internal processes related to controlled substances.</li><li>Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials</li><li>Collects and appropriately labels packaging retain samples, and submits to the archive storage</li><li>May execute computer data entries in CME, JDE, LIMS, and/or department databases.</li><li>Collects retain samples and performs sample evaluation for Annual Product Review.</li><li>May backup third party product review/release.</li><li>Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.</li></ul> Non-conforming events: <ul><li>Responds to and escalates events identified during production to Quality Management.</li><li>Participates in investigations with the Rapid Response Team as needed.</li></ul> Process Improvement: <ul><li>Collaborates with Manufacturing and Quality partners to identify and implement improvements.</li></ul> Compliance: <ul><li>Conducts GMP walkthroughs of facilities</li></ul> <ul><li>Learns how to perform in-process audits to identify adherence to SOPs and BR requirements.</li><li>Actively participates in training events, and maintains currency with assigned training requirements.</li></ul> Safety: <ul><li>Follows all procedures to ensure a safe and compliant work environment.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)</li><li>Ability to communicate and work with teams.</li><li>Attention to detail.</li><li>Strong documentation skills.</li><li>Ability to read and interpret SOPs and function within the scope of procedures.</li></ul>

Responsibilities: <ul><li>The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.</li><li>They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.</li><li>They will work with quality, technical operations and production to identify and resolve issues.&nbsp;</li><li>Adhere to all company and cGMP procedures as well as applicable safety regulations.</li><li>Author change controls, SOPs and protocols.</li><li>Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.</li><li>Responsible for confirming all communicated validation plans to applicable management.</li><li>Provides technical assistance in the form of rationales or validation studies.</li><li>Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.</li><li>Troubleshoots and resolves issues as needed.</li><li>Manage multiple projects with competing deadlines.</li><li>Manage external resources to complete tasks outside SPI’s capabilities.&nbsp;</li><li>Manage approvers of documents and procedures and ensure timely closure of tasks.</li><li>Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.</li><li>Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.</li><li>Source and procure equipment, supplies and other materials as needed.</li><li>Develop and maintain cross-functional relationships.&nbsp;</li></ul> Requirements: <ul><li>Bachelor of Science in Engineering or Science discipline preferred.</li><li>Experience in pharmaceutical (i.e. Validation/QA or R&amp;D), medical device, biotechnology industries.</li><li>In-depth knowledge of the pharmaceutical plant operations is an asset.</li><li>Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job</li><li>Experience authoring change controls in Trackwise or other management system.</li><li>Experience authoring SOPs in MasterControl or other management system.</li><li>Integrity – Works with integrity and ethically; 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>Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions.&nbsp;</li><li>People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.</li><li>Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.</li><li>Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.</li><li>Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.</li><li>Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.</li><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.</li></ul>

Responsibilities: <ul><li>To provide production and project support for laboratory computer systems, including system administration activities related to user account management, desktop support, instrumentation computer builds, hardware and software troubleshooting, technical support, and validation/qualification for new and existing systems.&nbsp;</li><li>This position will be responsible for providing Information Technology support for the following areas: QA, QC,&nbsp;</li></ul> <ul><li>Support Laboratory data collection and support applications.</li><li>Primary support for Waters Empower 3 application.</li><li>Support other lab systems including Malvern Particle Sizers, ICALIS-IDIS, OMNIC FTIR, Bruker XRD, ICP-Mass Spec, Imaging Software, UV/VIS Spectroscopy, Labware LIMS, Proveris Sprayview, LabX, PharmSpec HIAC, Vitek 2, Citrix, and others</li><li>Support and maintain Laboratory application servers, PC workstations.</li><li>Engage and work with support vendors to resolve issues in a timely manner with an understanding of the root cause.</li><li>Ensures lab systems daily back-ups are running.</li><li>Maintain lab file shares.</li><li>SOP Review and Development.</li><li>Work with all areas to develop process and technology-based solutions for their business needs.</li><li>Active participation in all systems implementations and technical development.</li><li>Manage the compliance level of all systems in accordance with corporate and regulatory standards.</li><li>Collaborate with other IT areas to address overall systems integrity, compliance, system integration and develop corporate IT/strategy.</li></ul> Manage user requirements&nbsp; <ul><li>Technical support for new implementations and upgrades.</li><li>Oversee Installation Qualifications (IQs), Operational Qualification (OQs), Performance Qualifications (PQs), 21 CFR part 11 testing, and acceptance testing as required</li><li>Interact with the business to understand business requirements at a functional / procedural level and translating these into technical design.</li><li>Generate specifications for configuration / development and implementation.</li><li>Document, train, and assist in system documentation.</li><li>Manage the full software development lifecycle (SDLC), including associated change management and validation processes.</li><li>Project Management skills for new implementations and upgrades.</li></ul> Provide ad hoc reports to satisfy client information requests <ul><li>Computer systems validation</li><li>Validate new systems or changes to existing systems, including the preparation and execution of qualification protocols.</li><li>Prepare necessary documents, e.g. user requirements, requirements traceability matrix.</li><li>Prepare / update systems governance, i.e. Standard Operating Procedures.</li><li>Perform necessary IT change controls for various systems.</li></ul> Data integrity and archiving Requirements: <ul><li>BS degree or equivalent work experience.</li><li>Minimum of 5 to 8 years of relevant experience.</li><li>Pharmaceutical/Life Science experience beneficial.</li><li>Strong knowledge of Waters Empower 3 application.</li><li>Experience with common laboratory equipment and software.</li><li>Experience with GAMP, CSV, CFR 21 Part 11.</li><li>Database (SQL Server/Oracle) experience a plus.</li><li>Trackwise Digital experience a plus.</li></ul> Avamar Backup experience a plus Skills &amp; Abilities: <ul><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>Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.</li><li>Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.</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>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>Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.</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>Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.</li><li>Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.</li><li>Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.</li></ul>

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11 chestnut ridge Jobs found

Process Engineer Technical Operation

QC Chemist I

Reliability Technician-Packaging

Office Manager & HR Generalist

QC Supervisor

Specialist, DEA Compliance

Supply Chain Manager

Associate I, Quality Operations

Validation Engineer

Laboratory Systems Analyst

WhiteCrow
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11 chestnut ridge Jobs found

Process Engineer Technical Operation

QC Chemist I

Reliability Technician-Packaging

Office Manager & HR Generalist

QC Supervisor

Specialist, DEA Compliance

Supply Chain Manager

Associate I, Quality Operations

Validation Engineer

Laboratory Systems Analyst

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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