Senior Manufacturing Engineer

Senior Manager-Advanced Quality Engineering

Chemist Data Reviewer

125112 Vision System Engineer

Specialist, DEA Compliance

QC Chemist I

Role Description: <ul><li>Manufacturing engineer is responsible for preparing the process sheets, tool design, establish overall strategic goals &amp; objectives of Manufacturing Engineering in alignment with organizational goals.&nbsp;</li><li>This role will be an individual contributor, which reports to MGR I MFG &amp; Process development engineer.&nbsp;</li></ul> Responsibilities:&nbsp; <ul><li>Analyze new technology and manufacturing processes. Plan and assess the feasibility of new and running projects.</li><li>Ensure good interfaces between Production, Production Planning, Engineering, QC and other functions.</li><li>Plan, design, and monitor manufacturing improvement processes using work study techniques.</li><li>Ensure Day to day accountability &amp; support Production team to achieve targets by process improvements, training, FAI etc.&nbsp;&nbsp;</li><li>Develop new process and create all process documents like PFC, PFMEA, Control plan and SOP by understanding the depth of product requirements.&nbsp;</li><li>Vendor management, Programming, Installation, and commissioning of new Equipment’s and co-ordinate with CFT for complete process validation.&nbsp;</li><li>NPI/NPD projects execution, development and creation of all required FAI documentations and approvals.&nbsp;</li><li>Implement Process monitoring and Control (SPC &amp; SQC), quality traceability Systems using IOT technology.&nbsp;</li><li>Create, Maintain &amp; Control all the programming software’s and production control documents for Auditing.&nbsp;</li><li>Vendor management and subcon handling and support for external projects.&nbsp;</li><li>Support production team to achieve day wise plan.&nbsp;</li><li>Prepare CT &amp; Investment for new product and work to reduce cost by optimization/automating process.&nbsp;</li><li>Responsible for ordering spares and vendor management, down time reduction Capacity &amp; Layout planning/execution for new product line.&nbsp;</li><li>Support manufacturing for Continuous Improvement, quality issues on the shopfloor, new launches, engineering changes.&nbsp;</li><li>Develop and implement systems that optimize all phases of production process. Conduct Root-Cause Analysis.&nbsp;&nbsp;</li><li>Review designs for manufacturing feasibility, suggest changes to the design to ensure product cost effectiveness.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>BE/ B. Tech (Industrial/Electronics, Mechanical).</li><li>Minimum 7 to 9 years of industrial experience with 4 years of project management experience.</li><li>Experience in quality &amp; productivity improvement projects.</li><li>Experience in New product development from scratch i.e. customer order to Production handover.</li></ul>

Responsibilities: <ul><li>Implement quality planning and controls for prototype/sample builds; manage build documentation.</li><li>Conduct Measurement System Analysis (MSA) for inspection systems and gauges.</li><li>Analyze samples and quality issues during development; drive corrective actions.</li><li>Ensure design verification and product qualification testing prior to project Gate 5.</li><li>Perform Process Capability Studies to support Final Tool Approval (FTAR) using CTAR methodology.</li><li>Establish and maintain quality controls and documentation for production environments.</li><li>Monitor process capability and oversee corrective actions as needed.</li><li>Approve measurement and cosmetic inspection criteria.</li><li>Support internal and external audits, including customer quality system audits.</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical, Mechanical Engineering, or related field.</li><li>10+ years of experience in quality control, preferably in cable assemblies, connectors, sockets, or similar industries.</li><li>Strong leadership capability and experience in managing people leaders across cultures.</li><li>Strong communicator with excellent written and verbal English skills.</li><li>Able to communicate effectively across all levels of the organization.</li><li>Trainer of quality tools and methodologies, with experience delivering workshops or coaching teams.</li><li>Deep understanding of ISO 9001, SPC, FMEA, MSA, and 7 QC tools.</li><li>Proficient in Statistical Process Control and Design of Experiments (DOE).</li><li>Demonstrated knowledge and experience with APQP methodology and requirements.</li><li>Familiarity with Model-Based Dimensioning (MBD) and GD&amp;T standards.</li><li>Expertise in EIA-364 test procedures.</li><li>Certified Internal/External Auditor; Six Sigma Black Belt preferred.</li><li>Skilled in quality software tools such as Minitab or JMP.</li><li>Strong organizational skills, strategic planning ability, and customer focus.</li><li>Proven ability to build effective cross-functional relationships and drive results.</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: Quality Documents Preparation and Revise. DQIP, Workmanship, Control Plan: <ul><li>Identify the key process basing on quality control and assure process quality.</li><li>Prepare DQIP, workmanship and Control Plan, and quality control document according to procedure.</li></ul> Setup &amp;F AAR: <ul><li>Basing on product, Process and procedure, review and approve Setup and FAAR report.</li></ul> MSA (GRR),gage: <ul><li>Do assessment on product and measurement tool, prepare MSA (GRR) report. Calibrate the inspection equipment as gage and process inspection machine to assure the efficiency.</li></ul> PFMEA: <ul><li>Assure the process risk control basing on efficient PFMEA.</li></ul> NCR &amp; QA instruction : <ul><li>NCR&amp; QA instruction prepare and confirmation, assure the good control on non confirming parts.</li></ul> Customer Quality: <ul><li>Fast response for customer complaints to drive customer satisfaction</li><li>Drive internal improvement and expansion based on customer complaints</li><li>8D CHS</li><li>8D report prepare and CHS system handling</li></ul> Process Improvement: <ul><li>In association with engineering department and production department to identify and analyze problems of production process, find out the root cause of failures</li><li>Do process capability analysis and defect statistic analysis, to increasing the product &amp; process quality</li><li>NPI product and process study to assure the NPI goes well on quality control.</li><li>Engage process improvement, confirm implementing and tracking effects and results</li></ul> Training: <ul><li>Providing practical training to QC and operators</li><li>Quality Improvement Summary and Sharing</li></ul> Requirements: Education,Technical Qualification &amp; Experience: <ul><li>Bachelor degree in technical or related major.&nbsp;</li><li>Minimum 1 year working experience in Quality management， connector working experience preferred.</li><li>English can be working language</li><li>MSA, SPC, FACA</li><li>Familiar with quality management tools, such as MSA, SPC, FACA etc</li></ul> Personal Attributes &amp; Competencies: <ul><li>Integrity; Accountability; Communication; Outgoing.</li><li>Good capability of logical thinking, self-study and independent problem solving</li></ul>

Role Description: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.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

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 qc chemist Jobs found

Senior Manufacturing Engineer

Senior Manager-Advanced Quality Engineering

Chemist Data Reviewer

125112 Vision System Engineer

Specialist, DEA Compliance

QC Chemist I

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6 qc chemist Jobs found

Senior Manufacturing Engineer

Senior Manager-Advanced Quality Engineering

Chemist Data Reviewer

125112 Vision System Engineer

Specialist, DEA Compliance

QC Chemist I

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

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