QC Chemist I

QC Supervisor

Reliability Technician-Packaging

Regulatory Affairs Manager

Validation Engineer

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: <ul><li>Develops and applies basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position. </li><li>Focused on a limited range of activities.&nbsp;</li><li>Completes routine tasks that are typically embedded in SOPs, operational or technical work practices and guidelines. Learns to identify deviations from accepted practice or procedure.</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.&nbsp;</li><li>Learns the responsibilities of being a team member. Participates as a team member. Collaborates primarily within the immediate work unit, which may be cross-functional.</li><li>Close supervision involving detailed instructions and requires regular checks on work performance.</li></ul> Requirements: <ul><li>HS diploma or equivalent with related certification, or HS diploma or equivalent with 2-4 years’ related experience.</li><li>Ability to use Blue Mountain for PM execution and utilization of Apple tablets to complete PMs and MSRs desired.&nbsp;</li><li>Ability to use and read test instruments.&nbsp;</li><li>Ability to learn pharmaceutical maintenance and cGMP processes.&nbsp;</li><li>Ability to learn to perform tasks and read basic schematics, technical drawings and/or blueprints.&nbsp;</li><li>Ability to learn set ups.&nbsp;</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.</li></ul> Knowledgeable in one or more of the following areas: <ul><li>Electrical</li><li>Hydraulic</li><li>Pneumatics</li><li>Mechanical</li><li>PLCs</li><li>Basic math, writing skills, and excellent problem solving abilities.&nbsp;</li><li>Basic computer skills.&nbsp;</li><li>Ability to use hand tools safely.&nbsp;</li></ul>

Responsibilities: Key Functions: <ul><li>Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products.</li><li>Responsible to maintain local SOPs and ensure compliance with regulations are met.</li><li>Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.</li><li>Provide support to commercial team from regulatory perspectives.</li><li>Poison License Holder, company pharmacist.</li><li>Primary contact with Regulatory Authority Department in the country.</li></ul> Regulatory : <ul><li>Product scope includes new molecules, generics, biosimilars, medical devices, diagnostics and OTC.</li><li>Lead local regulatory work for pharma division including new product/ device registrations, variations and renewals.</li><li>Conduct regulatory related submission/ correspondence with respective local health authorities (National Pharmaceutical Regulatory Agency NPRA and Medical Device Authority MDA).</li><li>Develop registration strategies, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives.&nbsp;</li><li>Review, analyze and coordinate data for new product submissions, line extensions according to priorities. Ensure up-to-date product registration, variation, line extension and other related law &amp; regulations knowledge.</li><li>Ensure that the content complies with government regulations prior to submission to Regulatory Authority.</li><li>Maintain an awareness of country’s regulatory legislation and assess its impact on company’s business.</li><li>Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.</li><li>Maintenance of regulatory related database and licences such as product technical files, product complaints and adverse drug reaction records, import and poison A licences, etc.</li></ul> Local SOPs and Policies : <ul><li>Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with NPRA and MDA requirements.</li><li>Lead applicable regulations and standards including cGMP and Safety; Compliance topics and quality systems such as GDP, Change Control, Data Integrity, auditing, and Complaint Handling.&nbsp;</li></ul> Support Marketing Activities : <ul><li>Conduct strategy meetings with commercial team to discuss product pipelines and registration plans.</li><li>Provide management with a monthly registration status.</li><li>Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.</li><li>Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.</li></ul> Pharmacovigilance (PV) and Quality Assurance (QA) Support : <ul><li>Lead local pharmacovigilance system in line with local regulatory requirements.&nbsp;</li><li>Drive maintenance and preparation of local quality management system and internal audit in compliance to local regulatory requirements,</li></ul> Requirements: Qualifications : <ul><li>Bachelor’s degree in pharmacy.</li><li>Registered pharmacist recognized by MOH Malaysia.</li><li>Experience in regulatory affairs in a pharmaceutical or medical device company.</li><li>Familiar with local regulatory bodies such as NPRA and MDA.</li><li>Strong initiative and ability to take lead on projects.</li></ul>

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

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5 cgmp Jobs found

QC Chemist I

QC Supervisor

Reliability Technician-Packaging

Regulatory Affairs Manager

Validation Engineer

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5 cgmp Jobs found

QC Chemist I

QC Supervisor

Reliability Technician-Packaging

Regulatory Affairs Manager

Validation Engineer

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

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