QC Officer

Chemist Data Reviewer

WET Process, Senior

CQE Shenzhen

Business Unit Head - Pharma / Pharma & Medical Device

QC Chemist I

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <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 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full 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.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong 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 coach less senior staff and develop laboratory skills and ability</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.&nbsp;</li><li>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>

Responsibilities: <ul><li>Drive cost reduction, weed out unwarranted expenses/wastages, find alternative sources and improve processes with innovative solutions to raise efficiency.</li><li>Drive quality investigations and continuous improvement programs to resolve chronic process and quality issues, and institute permanent resolutions to assure product quality and enhance process robustness.</li><li>Enforce on line controls and execution to conform to work instructions and procedures.&nbsp;</li><li>Apply hands-on and with deep involvement at work.</li><li>Coach, guide and train engineers and technicians in processes and problem solving and analysis to build up their technical competencies and achieve self-sustenance.</li><li>Take accountability of work and possesses strong sense of responsibility and team work.</li><li>Ensure non-conformance is dealt with in a proper and effective manner.</li><li>Establish, review and perform regular update of FMEA, OCAP, Process control, Risk Assessment and SIPOC on all critical processes to ensure a robust process.</li><li>Compliance with CSR, EHS, QM, ESD, 5S standard and cleanroom protocol.</li></ul> Requirements: <ul><li>Relevant knowledge of WET process and Semi-conductor WET equipment –SRD , WET Bench , WET etch , High pressure clean etc.</li><li>Able to identify cheaper source Chemical suppliers and Qualify new chemicals</li><li>Strong organizational, leadership, communications and interpersonal skills.</li><li>Systematic troubleshooting and problem-solving skills.</li><li>Application of quality and SPC tools at work.</li><li>Dynamic, resourceful, creative, innovative and self-driven.</li><li>A strong analytical mind and able to organize works to identify the root cause of problems.&nbsp;</li><li>Able to multi-task, set priorities and meet deadlines.</li></ul>

Responsibilities: Customer Quality Complaint Handling: <ul><li>Customer complaint initial check, on site investigation, CSR quick check &amp;support, strong driving ability to deliver solution for customer</li><li>Quick initial response or containment actions for customer</li><li>Publish complaint to company manufacturing plant and timely follow up</li><li>Internal 5D/8D driving / evaluation / on time deliver to customer</li><li>External 8D release and report to customer</li><li>Timely progress tracking, update and in time escalation</li><li>D6/LL/RA/CTP verification to make sure 8D effective closure&nbsp;</li></ul> Capability in Application &amp; Engineering:&nbsp; <ul><li>Good understanding of OEM production line assembly process</li><li>Strong problem solving ability &amp; tools capability like FTA, DOE...</li><li>Engineering basics such as GD&amp;T, good product &amp; application knowledges.</li><li>Sensitiveness to study/bench marking solutions from other competitors</li></ul> General quality topics coordination (internal &amp; external): <ul><li>Green scorecard driving with responsible key customers</li><li>Take leader as the pliot CQ leader for Chery, responsible for continues quality improvement coordination and regular meeting &amp; communication with various customer SQM interfaces.</li><li>Customer visit, CTP identify, proactive customer reporting &amp; quality workshop…coordination &amp;lead</li><li>Coordinate Training/Meeting/Audit/Quality documents...requested by customer&nbsp;</li><li>Manage the on site service people in Chery Wuhu, to deliver excellent service to customer</li></ul> Quality Data Analysis and Reporting: <ul><li>Maintain customer quality data in system/worksheet, timely tracking &amp; monitor.</li><li>Data analysis and reporting, performance tracking, improvement opportunity identify and driving.</li></ul> Requirements: <ul><li>Full-time degree or diploma holder</li><li>Minimum 3 years of customer quality experience </li><li>Previous exposure from automotive industry is preferred</li></ul>

Responsibilities: <ul><li>Articulate a clear vision for the business unit based on company objectives.&nbsp;</li><li>Responsible to define the strategy of BU based on market opportunities, customer needs and therapeutic franchise goals.&nbsp;</li><li>Deliver BU objectives and build a solid Annual Brand Plans, including revenue growth and financial target, commercial execution, profitability, expense control, process optimization, productivity, employee development, and customer satisfaction.</li><li>Collaborate with the Commercial Excellence team for forecasting &amp; analytics to develop appropriate forecasts to drive commercial success and accuracy.</li><li>Improving result by monitoring key operational metrics, measurements, and targets.</li><li>Develop strategy to manage and engage Key Opinion Leaders and key customers of our products, maintenance strong relationship with them.&nbsp;</li><li>Provide leadership and support to team, establish and lead high-performance team which includes talent identification, development plans and succession plans.</li></ul> Requirements: <ul><li>University Degree with Science education ( eg: pharmacy, medicine ). MBA is advantage.&nbsp;</li><li>A minimum 15 years successful sales and marketing experience in pharmaceutical, healthcare, medical devices both sales and marketing with mixed local pharmaceutical and global pharmaceutical experiences. </li><li>At least 8 year must be in managerial position.&nbsp;</li><li>Extensive experience in portfolio of Cardiovascular &amp; Metabolic, or Gastrointestinal, or Ob&amp;Gyn or Respiratory, or Neuroscience or Paediatric or Medical Device.&nbsp;</li><li>Ensure compliance with appropriate SOP’s, policies and guidelines.</li><li>Preferable someone with close engagement with multi medical association including internal medicines, gastrohepatologist, endocrinologist, cardiologist, neurologist, obstetric and gynaecologist, and surgeon.&nbsp;</li><li>Possesses strong understanding of market and sales strategy. Track record in defining, planning and shaping strategies and initiatives that set direction for business unit and/or function.</li><li>Proven successful track records in achieving sales target with entrepreneurial mindset.</li><li>Experience involving managing financial performance, P&amp;L responsibilities.</li><li>Experience with significant people demands, track record of attracting &amp; developing talent, developing bench strengths and managing complex, diverse and remote workforce (People Management &amp; development of team)</li><li>Client Interface</li></ul> Key Working Relationships <ul><li>Local and International KOLs</li><li>Main National &amp; Regional stakeholders</li><li>Medical societies and patient associations</li><li>Internal stakeholders incl. Medical Affairs, RA, Patient Access, Commercial Excellence &amp; HQ team</li></ul>

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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6 wet bench Jobs found

QC Officer

Chemist Data Reviewer

WET Process, Senior

CQE Shenzhen

Business Unit Head - Pharma / Pharma & Medical Device

QC Chemist I

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QC Officer

Chemist Data Reviewer

WET Process, Senior

CQE Shenzhen

Business Unit Head - Pharma / Pharma & Medical Device

QC Chemist I

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

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