Innovation Lead/ Research Scientist II

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

Manager, Quality Continuous Improvement

Responsibilities: <ul><li>Apply specialized scientific knowledge in creative ways to develop new innovative pharmaceutical products/processes.&nbsp;</li><li>Independently plan, execute and manage projects, incorporating advanced theories, methods and technologies in multiple disciplines to generate innovative solutions to complex problems where little clear precedence exists.</li><li>Leverage input from colleagues in R&amp;D and other functions e.g. Commercial, Clinical, Legal, and Manufacturing to create innovative products/processes/methods through novel combinations of expertise within the organization.&nbsp;</li><li>Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures.&nbsp;</li><li>Analyze executed designs and results and modify them to increase product/process acceptance, quality and reliability.</li><li>Identify opportunities for our intellectual property and work with Legal counsel to file patents.&nbsp;</li><li>Present research results at external conferences and publish articles in peer-reviewed scientific journals as appropriate.&nbsp;</li><li>Supervise and direct the laboratory work for a small team of lower level formulation and analytical scientists to facilitate rapid assessment of novel product formulation concepts, leveraging right first time/fail fast approach to evaluate and recommend promising product candidates to enter our product development process.</li><li>Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor and technical advisor to junior members within the discipline.</li></ul> Requirements: <ul><li>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.&nbsp;</li><li>Must possess strong knowledge of pharmaceutical formulation science and solid knowledge of related disciplines, plus knowledge of quality and general business systems.</li><li>Possess an in-depth knowledge and understanding of GxP and related regulations and guidance, and ability to leverage for efficient product design</li><li>Must possess strong ability to negotiate for resources and influence others internally and externally.</li><li>Must be able to challenge the status quo.</li><li>Must be able to contribute in setting strategic scientific direction for the organization and communicate the vision to his/her team members.&nbsp;</li><li>Can comfortably handle risk and uncertainty; can decide and act without having the total picture.</li></ul> Education and/or Experience: <ul><li>Include the education and/or experience that is necessary to perform the job satisfactorily.</li><li>Bachelors degree in a scientific discipline with at least 15 years of relevant experience, MS with at least 10 years, or PhD with at least 3-4 years of relevant experience.&nbsp;</li><li>QSR research experience is essential and GMP experience useful.</li><li>Lab experience includes research and/or development in GMP/QSR environment, leadership of technical teams, and technical leadership of drug product development programs.&nbsp;</li><li>Project management experience is desirable.</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>

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>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>Lead along all the departments the correct definition of standards and control methods in order to satisfy customers expectations, both in new and in existent processes. Organize the competent support to the whole organization in order to ensure an optimal and cost-effective quality assurance and contribute to the achievement of quality and volumes objectives.</li><li>Lead and drive the Customer Care activities and provide leadership application of CAPA process. Contribute to identify and deploy strategies to proactively lead improvement initiatives in line with the Company vision.</li><li>Establish a monitoring system for intermediates and finish goods providing statical evaluations and predictions.</li><li>In alignment with central QA strategies as well as internal/external stakeholders, provide direction/guidance/support to Quality Department in regard to FME and SVC sizing. Consistently apply OPEN+ systems and tools.</li><li>Ensure compliance to all and legal standards, policies and guidelines related to Environment, Health, Safety, Sustainability to prevent personnel, asset or societal loss.</li><li>Act and promote an interdependent and transparent safety culture fostering the utilization of preventive/predictive approach in line with Open+/IOS.</li><li>Proactively identify improvement opportunities, in line with the Organization vision, guarantee their implementation in order to lead product and process excellence, and assure excellent execution in term of cost, time and risks. Establish visual monitoring system (e.g Dashboards, KPIs) to track improvements and increase system efficacy. and visibility.</li><li>Manage corrective and preventive action system (CAPA) to continuously improve the final product quality and keep records of related actions. Proactively keep contacts with all the internal and external customers in order to continuously maintain updated the knowledge of Customers expectations.</li><li>Assure the Customer Care activities in term of complaints managing and analysis, in order to eliminate the causes of NC and customers dissatisfaction conditions. Proactively keep contacts with all the internal and external customers in order to continuously maintain updated the knowledge of customers’ expectations.</li><li>Determine and coordinate potential Product Related Special Situation management (PRSSM), including recalls, according to procedures. Define and implement a monitoring system for consumer and customer complaints through when appropriate historical data and trend analysis to identify potential deviations and preventive actions.&nbsp;</li><li>Ensure execution and update of monthly, weekly and on demand quality reports.</li><li>Act as Pillar Member of the assigned pillar</li><li>Contribute to the full year pillar plan definition and implementation aligned with OPEN+ Phase journey.</li><li>Participate and contribute to pillar reviews definition and implementation as per defined frequency.</li><li>Responsible for implementation of Standard work process defined in Pillars.</li><li>Ensure self-capabilities based on step-up cards.</li><li>Ensure monitoring system for intermediates and finish product quality performances is in place through historical Data &amp; Trend Analysis (DTA). Identify potential deviations and define preventive actions. Ensure execution and update of monthly, weekly and on demand quality reports.</li><li>Assure the Continuous Improvement (CI) culture within the organization as statistical expert coordinator within the Organization. Lead training to the whole organization in the field of statistics and SPC in order to continuously sustain the CI Organization. Operate as a point of reference for all the SPC and statistics concepts and ensure the support for ad hoc request.</li><li>In relation with Manufacturing and Q Ops SDDS, projects and initiatives give direction/guidance/support to Quality Department in the sizing definition and appropriate optimization of FME and SVC in order to guarantee proper support with full respect of quality standards</li><li>In liaison with central functions and functional QA departments define and maintain integrated capacity plans for selected key QA processes/activities.</li><li>Support the Q Manager in in the definition and deployment of departmental objectives of Quality Department as per Manufacturing and Q Ops SDDS cycle.</li><li>Support the Q Manager in the definition and finalization of the budget for Quality department along all OB and RF phases.</li><li>Manage and develop a motivated and skilled team to ensure performance levels, professional development, and achievement of objectives, in respect of leadership model.</li><li>Create an environment in which each member of the team is motivated to express own talent and potential.</li><li>Develop and drive the execution of a Qualification matrix and training path for each role.</li></ul> Requirements: <ul><li>Master’s degree in Quality Management, Biological Sciences, Physical Sciences, Engineering or similar.</li><li>Experience in the tobacco, food or pharmaceutical industry.</li><li>Senior experience in Quality Management (5+ direct reports, 30+ indirect reports).</li><li>Experience in lean methodologies.</li><li>Product and process qualification; Analytical skills; Strong ability to transform data into information (reporting skills); Excellent know how on relevant standards (ISO, GMP, GCP, ICH, GLP, etc.).</li><li>Fluent level of written and spoken English (Dutch is a strong plus).</li></ul>

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Innovation Lead/ Research Scientist II

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

Manager, Quality Continuous Improvement

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Innovation Lead/ Research Scientist II

Associate I, Quality Operations

Specialist, DEA Compliance

QC Chemist I

Manager, Quality Continuous Improvement

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

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