Manager II, MPDE

QC Supervisor

ASC - Downstream Data Scientist

Validation Engineer

HR Systems Supervisor - Workday Reporting Administrator

HR Systems Supervisor - Workday HCM/Compensation

Responsibilities: <ul><li>Manages the Advance Manufacturing Process (AMP*) team in Asia Pacific comprised of experienced professionals and/or supervisors who exercise latitude and independence in their assignments.&nbsp;</li><li>Develops the organization to support AMP operational strategy, defines and implements operational plans, and has measurable impact on operating efficiencies and organizational objectives.</li><li>Responsible for project and compliance, assessing risk and compliance across the AMP function.&nbsp;</li><li>Analyzes and plans work force utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.&nbsp;</li><li>Develops and administers schedules and performance requirements and have budget planning and management responsibilities.&nbsp;</li><li>Performs staff responsibilities, including interviewing and performance management.&nbsp;</li><li>Builds and grow individuals and teams.</li><li>Frequently interacts with multiple organizational levels and interactions normally require the ability to gain cooperation of others.&nbsp;</li><li>Provides strategic leadership to foster growth of the business.&nbsp;</li><li>Provides input on resolving key issues that directly impact the AMP function.&nbsp;</li><li>Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.&nbsp;</li><li>Determines best course of action to meet schedules and/or resolve technical problems.&nbsp;</li><li>Adapts/makes departures from traditional approaches to enhance quality or value in existing methods.&nbsp;</li></ul> Requirements: <ul><li>Minimum 12 years of related experience.</li><li>Bachelor’s Degree (Mechanical Engineering or related) required, Master’s preferred.</li><li>Broad Management, Technical and Project Experience with Deep Knowledge in Advance Manufacturing Process (* Manufacturing technology/capabilities development for Stamping, Plating, Assembly, Molding).</li><li>Fluent in English/Mandarin (read, write, and speak) is a must.</li><li>Competent knowledge with quality tools (FMEA, Six Sigma, DOE, 8D/Continuous Improvement), is a plus!</li><li>Broad project management process skill and experience</li><li>Practical application of MS Office software (Word, Excel, PPT, Project, &amp; Outlook).&nbsp;</li><li>Based in China-Qingdao mfg. site and willingness to travel up to 25% average.</li></ul>

Responsibilities: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.Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.  Testing: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.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.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.   Documentation Practice, Training and Compliance:Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.  Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.Lab Maintenance:Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.  Staff Development: Evaluate potential candidates for QC; prepare annual performance evals. for chemists.   Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.Requirements:Education & Experience:BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge:Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.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.Skills & Abilities:Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.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.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.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.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.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.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.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.Good verbal and written communications with basic computer skills.Physical Requirements: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.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment. Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate. The work environment is representative of a group laboratory environment. 

Responsibilities:Formulates and leads guided, multifaceted analytic studies against large volumes of data.Interprets and analyzes data using exploratory mathematic and statistical techniques based on the scientific method.Coordinates research and analytic activities utilizing various data points (unstructured and structured) and employ programming to clean, massage, and organize the data.Experiments against data points, provide information based on experiment results and provide previously undiscovered solutions to command data challenges.Leads all data experiments tasked by the Data Science Team.Coordinates with Data Engineers to build data environments providing data identified by Data Analysts, Data Integrators, Knowledge Managers, and Intel Analysts.Develops methodology and processes for prioritization and scheduling of projects.Analyzes problems and determines root causes.Defines company data assets (data models), spark, sparkSQL, and hiveSQL jobs to populate data models.Works closely with all business units and engineering teams to develop strategy for long term data platform architecture.Requirements:Master’s degree in Operations Research, Industrial Engineering, Applied Mathematics, Statistics, Physics, Computer Science, or related fields5-7 years of professional experienceProficient with one or more programming languages (Java, C++, Python, R, etc.)Demonstrated experience applying data science methods to real-world data problemsExperience utilizing visualization tools to take advantage of the growing volume of available informationData Scientist Qualifications / Skills:Advanced analytical knowledge of dataConducting big data analysisData conditioningProgramming advanced computingDeveloping algorithmsDeveloping software and data modelsExecuting predictive analytics

Responsibilities: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.They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.They will work with quality, technical operations and production to identify and resolve issues. Adhere to all company and cGMP procedures as well as applicable safety regulations.Author change controls, SOPs and protocols.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.Responsible for confirming all communicated validation plans to applicable management.Provides technical assistance in the form of rationales or validation studies.Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.Troubleshoots and resolves issues as needed.Manage multiple projects with competing deadlines.Manage external resources to complete tasks outside SPI’s capabilities. Manage approvers of documents and procedures and ensure timely closure of tasks.Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.Source and procure equipment, supplies and other materials as needed.Develop and maintain cross-functional relationships. Requirements:Bachelor of Science in Engineering or Science discipline preferred.Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries.In-depth knowledge of the pharmaceutical plant operations is an asset.Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the JobExperience authoring change controls in Trackwise or other management system.Experience authoring SOPs in MasterControl or other management system.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.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. 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.Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.Climb ladders and work in high, precarious places up to elevations of 75 feet.Regularly exposed to work near moving mechanical parts.Exposed to wet or humid conditions.Exposed to outdoor weather conditions.Regularly exposed to high noise environments.Exposed to extremely dusty environments.Exposed to chemicals used in the manufacturing process.

Role Description:This position performs research on, designs, develops, and implements current and future global Human Resources Systems/Integrations and delivers project related documents (i.e., requirements documents, design documents, request for proposal, test case development etc.). This position collaborates with organizational stakeholders, internal and external Information Technology (IT) groups, vendors, and senior management to establish and implement systems and processes that reduce errors and improve efficiency. Responsibilities:Configures Workday Reporting (Report Administrator) – supports group of decentralized report writers.Configures Workday Prism – upload of data and table creation for reporting purposes. Works with Reporting Team on reports.Configures Workday Adaptive Planning – configuration/support of reporting of planned vs. open Position Management position.Manages test scripts and defects.Reviews and analyzes recurring issues to identify possible problem triggers and best resolution.Supports security and internal/external systems audits and ensures system access meets compliance.Manages reported production issues though help desk case management tool and works with internal work groups and external vendors on resolutions.Evaluates impact of new and modified applications/integrations to determine their effect on existing applications and works with IT to coordinate conversions of existing applications.Maintains foundational data in HR Systems (Job Profiles, Department IDs, Cost Centers, etc.) Conducts data audits to identify inconsistencies in data sets between HR Systems, IDH, and payrollRequirements: Bachelor’s degree or international equivalent.Preferences: Previous HR Systems experience with SaaS solutions (Workday) or HR functional knowledge of HR processes.Ability to support global time zones as needed for systems testing and releases.

Overview:This position performs research on, designs, develops, and implements current and future global Human Resources Systems/Integrations and delivers project related documents (i.e., requirements documents, design documents, request for proposal, test case development etc.).This position collaborates with organizational stakeholders, internal and external Information Technology (IT) groups, vendors, and senior management to establish and implement systems and processes that reduce errors and improve efficiency. Responsibilities:Configures Workday Recruiting in partnership with IT and external vendor(s). Responsibilities include business processes, grade profiles, salary ranges, eligibility rules, validation rules, notifications.Prepare EIB Mass Data Templates to upload into Workday.Manages test scripts and defects.Reviews and analyzes recurring issues to identify possible problem triggers and best resolution.Supports security and internal/external systems audits and ensures system access meets compliance.Manages reported production issues though help desk case management tool and works with internal work groups and external vendors on resolutions.Evaluates impact of new and modified applications/integrations to determine their effect on existing applications and works with IT to coordinate conversions of existing applications.Maintains foundational data in HR Systems (Job Profiles, Department IDs, Cost Centers, etc.) Conducts data audits to identify inconsistencies in data sets between HR Systems, IDH, and payrollRequirements: Qualification:Bachelor’s degree or international equivalentPreferences: Previous HR Systems experience with SaaS solutions (Workday) or HR functional knowledge of HR processes.Ability to support global time zones as needed for systems testing and releases.

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6 analyzes Jobs found

Manager II, MPDE

QC Supervisor

ASC - Downstream Data Scientist

Validation Engineer

HR Systems Supervisor - Workday Reporting Administrator

HR Systems Supervisor - Workday HCM/Compensation

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6 analyzes Jobs found

Manager II, MPDE

QC Supervisor

ASC - Downstream Data Scientist

Validation Engineer

HR Systems Supervisor - Workday Reporting Administrator

HR Systems Supervisor - Workday HCM/Compensation

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

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