QC Chemist I

QC Supervisor

Petrophysicist

Art Director (3D Modelling)

Specialist, DEA Compliance

Buyer/Planner, Production Planning

Laboratory Systems Analyst

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

Responsibilities : &nbsp;<ul><li>Conduct advanced well log data interpretation</li><li>Determine petrophysical parameters such as net pay, porosity, saturation, permeability etc.</li><li>Evaluate and integrate core, log, sampling, and test data</li><li>Conduct fluid distribution studies and determine contacts for proven, probable and possible cases</li><li>Apply the latest technology and efficient workflows to generate petrophysical work processes</li><li>Collaborate with resource Petro physicists, geoscientists and engineers to conduct accurate assessments</li><li>Follow up well operations, propose and provide technical advice on data acquisition, coring, and testing operations</li><li>Evaluate and normalize field wide petrophysical data</li><li>Train, mentor and develop the young professionals on relevant skills.</li></ul>&nbsp;Requirements:&nbsp;<ul><li>Bachelors degree&nbsp;in Geosciences or related field (e.g., Geology, Geophysics, Petrophysics, or other related science and engineering fields) is required. An advanced degree is preferred.</li><li>An extensive formal experience in petrophysical evaluation and resource assessment related studies is desirable.</li><li>A minimum of 15 years of experience. An extensive experience in petrophysical studies and at least 5-10 years of professional experience in well log interpretation.</li><li>Significant knowledge of logging and core analysis techniques</li><li>Experience in QC and validation of single and multi-well petrophysical evaluation interpretation results dedicated for 2D and 3D Pore Volume Assessment.</li><li>Conduct sensitivity analysis on modelling parameters and uncertainties, highlighting their impact on volumes.</li><li>Have good exposure to different petrophysical evaluation methods, understand and QC MICP and saturation height functions with detailed analysis.</li><li>Conduct technical studies related to petrophysical applications in resource assessments</li><li>Good communication, report writing and presentation skills in English.</li></ul>

Responsibilities: <ul><li>Understand client’s requirements and artistic style of various projects. Provide art guidance for Chinese production team&nbsp;</li><li>Responsible/answer to the client for the visual direction and QC of work.&nbsp;</li><li>Building rapport, trust, and clear lines of communication with clients.&nbsp;</li><li>Help with estimation, team feedback and pipeline development.&nbsp;</li><li>Leading teams of artists by instruction and setting example.&nbsp;</li><li>Define and communicate the key components of the project style and design.</li><li>Collaborate with different 3D Art teams, coordinate resources and projects between multiple internal Chinese and external teams and studios.&nbsp;</li></ul> Requirements: <ul><li>Passionate about games, proven 3+ years art leadership working experience as in either the game industry or related entertainment industry.&nbsp;</li><li>Excellent Chinese and English (written and verbal) skills.&nbsp;</li><li>Strong game production work experience showcasing top quality work.&nbsp;</li><li>Ability to work in multiple software packages and game engines (i.e. 3DS Max, Maya, Zbrush, Unreal, Unity).&nbsp;</li><li>Expert understanding of industry standard techniques and tools.&nbsp;</li><li>Excellent communication skills, with an understanding for the value of listening to as well as providing feedback, confidence to ask the right questions.&nbsp;</li><li>Team Player, quick learner and self-motivated.&nbsp;</li><li>Enthusiasm to expand knowledge in keeping with industry evolution.&nbsp;</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>On a weekly basis, review the Material Resource Plan (MRP) output and align requirements based on the latest version of the artwork for printed packaging components. Upon finalizing the requirements convert/consolidate planned orders to Purchase orders</li><li>On a daily basis, analyze, approve and communicate orders to the suppliers. This will include new orders and/or changes to previous releases. Initiates follow up on orders placed; expedite deliveries</li><li>Keep the Purchasing Manager and Master Production Scheduler informed of delivery changes that might affect production</li><li>Monitor and report quality and delivery metrics of supplied lots on a monthly basis to monitor and report quality and delivery dates weekly</li><li>Perform priority Quality Control (QC) testing</li><li>Review and update open purchased order report</li><li>Approve and process requisitions</li><li>Attend weekly bulk and packaging meeting</li><li>Prepare updates for new product launches</li><li>Communication with label compliance on new or revised label and outset changes</li><li>Monitor inventory performance against plan and initiate actions where variances arise. Take corrective action on those items that are not within established inventory levels. Follow up any claims to suppliers that may arise on purchased materials.</li><li>Review weekly and monthly shortages</li><li>Maintain control of packaging changes to assure that these changes are introduced efficiently and write offs are reduced to a minimum.</li><li>Provide forecasts to suppliers on Active Ingredients and Packaging Components based on the MRP requirements.</li><li>Anticipate emergency conditions such as vendor strikes, supply chain issues or shut downs and take necessary actions to reduce their effect on operations</li><li>Provide forecast to key suppliers</li><li>Review Accounts Payable (AP) issues</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelors’ Degree (B.S.) from a four-year college or university in a Finance, Logistics, or Business discipline.</li><li>Minimum of 5 years’ experience in structured planning environment or equivalent combination of education and experience</li><li>Advanced expertise in MRP / systems supported planning</li><li>Working knowledge of SAP preferred</li></ul>

Responsibilities: <ul><li>To provide production and project support for laboratory computer systems, including system administration activities related to user account management, desktop support, instrumentation computer builds, hardware and software troubleshooting, technical support, and validation/qualification for new and existing systems.&nbsp;</li><li>This position will be responsible for providing Information Technology support for the following areas: QA, QC,&nbsp;</li></ul> <ul><li>Support Laboratory data collection and support applications.</li><li>Primary support for Waters Empower 3 application.</li><li>Support other lab systems including Malvern Particle Sizers, ICALIS-IDIS, OMNIC FTIR, Bruker XRD, ICP-Mass Spec, Imaging Software, UV/VIS Spectroscopy, Labware LIMS, Proveris Sprayview, LabX, PharmSpec HIAC, Vitek 2, Citrix, and others</li><li>Support and maintain Laboratory application servers, PC workstations.</li><li>Engage and work with support vendors to resolve issues in a timely manner with an understanding of the root cause.</li><li>Ensures lab systems daily back-ups are running.</li><li>Maintain lab file shares.</li><li>SOP Review and Development.</li><li>Work with all areas to develop process and technology-based solutions for their business needs.</li><li>Active participation in all systems implementations and technical development.</li><li>Manage the compliance level of all systems in accordance with corporate and regulatory standards.</li><li>Collaborate with other IT areas to address overall systems integrity, compliance, system integration and develop corporate IT/strategy.</li></ul> Manage user requirements&nbsp; <ul><li>Technical support for new implementations and upgrades.</li><li>Oversee Installation Qualifications (IQs), Operational Qualification (OQs), Performance Qualifications (PQs), 21 CFR part 11 testing, and acceptance testing as required</li><li>Interact with the business to understand business requirements at a functional / procedural level and translating these into technical design.</li><li>Generate specifications for configuration / development and implementation.</li><li>Document, train, and assist in system documentation.</li><li>Manage the full software development lifecycle (SDLC), including associated change management and validation processes.</li><li>Project Management skills for new implementations and upgrades.</li></ul> Provide ad hoc reports to satisfy client information requests <ul><li>Computer systems validation</li><li>Validate new systems or changes to existing systems, including the preparation and execution of qualification protocols.</li><li>Prepare necessary documents, e.g. user requirements, requirements traceability matrix.</li><li>Prepare / update systems governance, i.e. Standard Operating Procedures.</li><li>Perform necessary IT change controls for various systems.</li></ul> Data integrity and archiving Requirements: <ul><li>BS degree or equivalent work experience.</li><li>Minimum of 5 to 8 years of relevant experience.</li><li>Pharmaceutical/Life Science experience beneficial.</li><li>Strong knowledge of Waters Empower 3 application.</li><li>Experience with common laboratory equipment and software.</li><li>Experience with GAMP, CSV, CFR 21 Part 11.</li><li>Database (SQL Server/Oracle) experience a plus.</li><li>Trackwise Digital experience a plus.</li></ul> Avamar Backup experience a plus Skills &amp; Abilities: <ul><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>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.</li><li>Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.</li><li>Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</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>Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.</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>Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.</li><li>Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.</li><li>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.</li></ul>

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7 qc chemist Jobs found

QC Chemist I

QC Supervisor

Petrophysicist

Art Director (3D Modelling)

Specialist, DEA Compliance

Buyer/Planner, Production Planning

Laboratory Systems Analyst

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7 qc chemist Jobs found

QC Chemist I

QC Supervisor

Petrophysicist

Art Director (3D Modelling)

Specialist, DEA Compliance

Buyer/Planner, Production Planning

Laboratory Systems Analyst

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.