Quality Control Supervisor

Senior Quality Engineer

Head of HSE, Horn of Africa

Lead Quality Specialist - Investigator

Customer Care Manager

CQE Shenzhen

Associate I, Quality Operations

Validation Engineer

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><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>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>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</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>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><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>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Develop and implement quality standards to meet Quality Management System to assure products meet or exceed customer expectations.</li><li>Lead cross-functional problem-solving teams; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions</li><li>Performs routine supplier and plant audits to ensure product being manufactured meets all requirements.</li><li>Lead cross-functional teams to drive process and product improvements in manufacturing plants and at suppliers.</li><li>Work with Manufacturing, Engineering, and PM to determine product specifications and tolerances.</li><li>Participates in various NPI projects to ensure quality is incorporated into product designs and be responsible for preparing all quality-related documentation.</li><li>Support the development of FMEAs, Control Plans, Test and Inspection Plans.</li><li>Establish and maintain control plans to assure critical features are controlled through manufacturing processes.</li><li>Reviews and integrates contractual requirements into all aspects of proposals and program processes and documentation.</li><li>Conducts capability assessments and process validations to support supplier selection activities.</li><li>Provides material review dispositions for non-conforming materials or products.</li><li>Plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables.</li><li>Update company complaint handling system to ensure capture, investigation, and proper documentation of all customer complaints.</li><li>Manage documents related to ISO certification, procedures, standards, customer change requests, ECN, PCN, and/or Work Instructions.</li></ul> Requirements: <ul><li>Bachelor’s degree, Engineering or related technical discipline.</li><li>8+ years’ experience in Quality Engineer role in a production environment.</li><li>Familiarity with ISO 9001, AS9100 or ISO/TS 16949 QMS standards.</li><li>Experience in reading blueprints and have basic understanding of GD&amp;T fundamentals.</li><li>Experience effectively utilizing statistical methods and statistical analysis tools.</li><li>Experience with APQP, PPAP, FMEA, Control Plans, and various problem solving tools.</li><li>Experience in statistical tools and disciplined problem-solving methodologies such as 8D, A3, DMAIC, Fishbone,5-Whys, 6Ms.</li><li>Self-motivated, proactive and efficient team player who thrives in a fast-paced environment.</li><li>Able to travel 20% - 30% domestically and 10% internationally.</li><li>Must be eligible to work in the US with no sponsorship now or in the future.</li><li>Technical understanding of electrical power systems and electrical power distribution/circuit protection products.</li><li>Six Sigma Green, Black Belt, or comparable certification, preferred.</li><li>Excellent communication skills written, verbal, and presentation skills with effective technical writing skills, ability to speak Spanish is a plus.</li><li>High-energy, results-oriented, self-reliant, team player who can positively collaborate across different business departments and cultures.</li><li>Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)</li><li>Experience in the electrical-mechanical manufacturing or solar industry.</li><li>Experience in conducting supplier and plant audits.</li><li>Experience in reviewing customer contracts.</li></ul>

Role Description: <ul><li>To ensure that work processes are implemented as designed and comply with established policies, processes, and procedures.</li><li>Ensure compliance with both standard and regulatory requirements as relevant for all entities in the Horn of Africa.</li></ul> Responsibilities: <ul><li>Play a lead role in promoting and developing safe work culture that embraces zero harm through health, safety and environmental awareness by stimulating active involvement and interaction at all organizational levels.</li><li>Maintain the safety standards to be in compliance with company HSE policies and countries legislations.</li><li>Collate and analyse data for trend analysis &amp; statistics at regular intervals to achieve continual improvement on all aspects of HSE and related training of personnel.</li><li>Involve in high level investigation &amp; Investigate accidents effectively and determine root cause analysis along with project clients.</li><li>Identify and act upon opportunities for improvement to safety related matters.</li><li>Liaise with project managers / client / stakeholders as deemed necessary for discussion on project safety matters and resolve issues.</li><li>Drive and support the business in implementing HSE standards for contracts and suppliers through the HSE team in each business unit.</li><li>Provide advice and support to line management for conducting risk assessments and ensuring that operational risks are proactively and appropriately managed.</li><li>Overview and ensure proper adherence to ICAM procedure for incident investigations and implement effective control measures for closure of the gaps identified to prevent recurrence.</li><li>Evaluate and ensure emergency response preparedness through regular emergency mock drills and upkeep of the emergency response procedures.</li></ul> Requirements: <ul><li>Post Graduate qualification in Safety with at least 15 yrs work experience in the field of Safety Management and Training; OR</li><li>Graduate in any field with Diploma in Industrial Safety with at least 10 yrs work experience in Safety Management and Training; OR</li><li>Knowledge of ISO and other International Standards related to Quality, Environment and Occupational Health &amp; Safety</li><li>Lead Auditor certification in Quality Management System</li><li>Computer literate in Microsoft Office applications</li><li>Very good communication in English 	</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Responsibilities: <ul><li>Analyse the technical complaints of the vehicle in the field visits.</li><li>Rectify defects in vehicles / overhaul aggregates.</li><li>Maintain and handle internet-based warranty.</li><li>Ensure implementation of service processes at channel partners.</li><li>Joint Investigation along with vendors.</li><li>Development of secondary channel.</li><li>Feedback on companies as well as competitors’ products.</li><li>Training of service managers.</li><li>Work out special service support for strategic customers with channel partners.</li><li>Ensure execution of spare parts order by all channel partners for sufficient inventory and for meeting spare parts target.</li><li>Secondary network for spare parts sales.</li><li>Guide channel partners for manpower/facilities/equipment optimisation.</li><li>Ensure profitability of workshops of channel partners.</li><li>MIS on service.</li><li>Spare parts inventory management.</li><li>Manging service guarantee at the dealership.</li><li>Monthly visit to ASC and monitor his performance along with ASC coordinator.</li><li>Service camps on monthly basics.</li><li>Monthly visits to customer and update M Response data</li></ul> Requirements: <ul><li>Technical knowledge of BS6 Products</li><li>Exp. in Commercial Vehicle Segment</li><li>Exp. in Dealership Management/Field Service Management</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:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

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.

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9 geotechnical investigation Jobs found

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Head of HSE, Horn of Africa

Lead Quality Specialist - Investigator

Customer Care Manager

CQE Shenzhen

Associate I, Quality Operations

Validation Engineer

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9 geotechnical investigation Jobs found

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Head of HSE, Horn of Africa

Lead Quality Specialist - Investigator

Customer Care Manager

CQE Shenzhen

Associate I, Quality Operations

Validation Engineer

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

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