Quality Assurance Associate

QC Supervisor

Process Operator

Accounts Payable Associate

Talent Acquisition Lead

QC Chemist I

Laboratory Systems Analyst

Responsibilities: <ul><li>Primary responsibilities of this role include the following:</li><li>With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.</li><li>Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.</li><li>Support Drug Product Recall/Field alert management.</li><li>Assist with review of Quality Agreements.</li><li>For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.</li><li>With supervision, review deviations/investigations related to the companys frontend products.</li><li>Assist with SOP management for the company’s US corporate office.</li><li>Support with quality matters for disposition of product returns.</li><li>Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.</li></ul> Requirements: <ul><li>Excellent verbal and written communication skills are necessary.</li><li>With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.</li><li>Motivated, results driven with attention to detail, accuracy and clarity.</li></ul> Qualifications:&nbsp; <ul><li>BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.</li><li>Recent graduates will be considered for this role.&nbsp;</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>Ensure production targets are met while maintaining compliance with Life Critical Procedures, Tenets of Operations, Consent to Operate, plant policies and procedures, Daily Operating Instructions, Standard Operating Procedures (SOPs) and Job Safety Analyses (JSAs).</li><li>Monitors process conditions and makes necessary adjustments in order to optimize the process while ensuring products are within the required specifications.</li><li>Document critical activities and abnormalities via operator’s log.</li><li>Perform comprehensive shift turnover.</li><li>Timely completion of all compliance training.</li><li>Ensure correct mitigations are in place for emergency &amp; safety bypass permits.</li><li>Issue Work Permits and authorize the unit entry.</li><li>Responsible for housekeeping in work area.&nbsp;</li><li>Advise support groups on housekeeping needs.</li><li>Conduct detailed, quality rounds and complete e-SOMS tours in the plant, log all abnormalities and required follow up in the Narrative log.&nbsp;</li><li>Report abnormalities to Shift Supervisor and take the necessary corrective actions.</li><li>Participate in Safety and Reliability Improvement teams as required.</li><li>Certify in the areas as decided by plant leadership and mentor for new employees.</li><li>Take corrective actions to keep all the process parameters within its design limits.</li><li>Work with and assist Technical and Maintenance to understand and solve the process problems.</li><li>Prepare and commission equipment per DOI’s and Maintenance Schedule.</li><li>Perform unit start-ups, normal operation, process upsets and shutdowns as per SOP and EOP requirements.</li><li>If certified as Board Operator, work on DCS Board and communicate with upstream/downstream units on any process upset/problems.</li><li>Follow and review SOP’s and EOP’s, give feedback Supervisor / Training Coach if SOP needs revisions or modifications.</li><li>Work with Turnaround Planning to develop production plans and work packages.&nbsp;</li><li>Support other operating units in TA as applicable.</li><li>Unload CCA and collect process / product samples as required.</li></ul> Quality, Health, Security, Safety and Environment: <ul><li>Ensure compliance with Life Critical Procedures, Tenets of Operations, Consent to Operate, plant policies and procedures, Daily Operating Instructions, Standard Operating Procedures (SOPs), Job Safety Analyses (JSAs), MOC Process, and Quality Management System.</li><li>Participate in the safety activities of the shift to ensure regulatory, health, safety, security, environmental, and quality compliance.</li><li>Carry out plant walk-downs and audits to ensure work is being performed safely and that the plant safety systems are enabled.&nbsp;</li><li>Coordinate efforts to correct discrepancies.</li><li>Actively participates in shift toolbox meetings, JSAs, MSCM’s, etc.</li><li>Execute Stop Work Authority and take immediate corrective actions to stop unsafe behaviors.</li></ul> Policies, Systems, Processes and Procedures: <ul><li>Contribute to the identification of opportunities for the continuous improvement of systems, processes and practices in order to increase productivity and operational efficiency.</li><li>Implement all relevant Section’s policies, processes, procedures and instructions so that work is carried out in a controlled and consistent manner.</li></ul> Reporting: <ul><li>Prepare timely and accurate recaps and reports in order to meet departmental requirements, policies and standards.</li><li>Communicate to Shift Supervisor to inform on issues that require additional follow up.</li><li>Report incidents and near misses and participate in investigations as required.</li></ul> Qatarization: <ul><li>Contribute to the development of Qatari employees.&nbsp;</li><li>This accountability is applicable to expatriate employees only.</li></ul> Requirements: Education: <ul><li>Required: High School Diploma with Tertiary Vocational Diploma</li><li>Preferred: 3-year Diploma or Bachelor’s degree</li></ul> Experience: <ul><li>Required: 3-5 years of similar experience in the O&amp;G Industry</li><li>Preferred: 3-5 years of similar experience in Petrochemicals Production Facility</li></ul>

Responsibilities: <ul><li>Process vendor invoices, ensuring accuracy, completeness, and compliance with company policies and procedures.</li><li>Verify invoice details, including prices, quantities, and terms, and resolve any discrepancies or issues with vendors or internal stakeholders.</li><li>Reconcile accounts payable transactions and resolve any discrepancies with vendors or internal departments.</li><li>Collaborate with internal stakeholders to resolve invoice and payment-related inquiries in a timely manner.</li><li>Assist with month-end and year-end closing activities.</li><li>Support the implementation of process improvements to enhance efficiency, accuracy, and controls within the accounts payable function.</li><li>Adhere to financial policies, procedures, and internal controls (SOX) to ensure compliance with regulatory requirements.</li><li>Maintain regular updates to the invoice processing documentation (SOP).</li></ul> Requirements: <ul><li>Minimum 4 years of experience in accounts payable processing US/EMEA Purchase invoices in ERP (preferably SAP).</li><li>Strong analytical skills with the ability to analyze and interpret financial data.</li><li>Exceptional attention to detail and accuracy, ensuring high-quality deliverables.</li><li>Proficient in using accounting software and MS Office applications, particularly Excel.</li><li>Excellent organizational and time management skills, with the ability to prioritize and meet deadlines.</li><li>Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</li><li>Knowledge of accounting principles and understanding of accounts payable processes and controls.</li><li>Ability to maintain confidentiality and handle sensitive information with integrity.</li></ul>

Responsibilities: <ul><li>Perform end-to-end recruitment life cycle in compliance with the relevant methodologies, policies, and regulations for the assigned region.</li><li>Perform hiring manager and stake holder management activities and ensure a positive experience between the transactions.</li><li>Participate and collaborate in intake meetings to understand recruiting needs, selection strategy, and update stakeholders with candidate/interview feedback, and salary negotiations and approvals.</li><li>Proactively perform sourcing strategies through relevant online channels, job boards, professional social media, and other sourcing portals to ensure an active candidate pipeline.</li><li>Perform candidate management activities to maintain strong relationship with past and potential candidates through active update on new requisitions and existing applications.</li><li>Accurately document all candidate information and recruiting activities in the applicant tracking system.</li><li>Develop, organize, and perform talent branding activities, employee referral processes, and internal mobility programs.</li><li>Prepare and extend job offers, and coordinate with internal stakeholders in the negotiation of successful candidates.</li><li>Support in the development and information gathering activities to develop recruitment reports and strategies for presentation with stakeholders.</li><li>Escalate issues and recommend resolutions to the Team Lead for timely. </li><li>May support junior members of the team in addressing routine issues within the assigned processes.</li><li>Maintain the SOP/DTP of current processes and incorporate documentation updates as required.</li><li>Propose alternatives in identified issues and assist in investigating and in resolving common and unusual issues.</li><li>Contribute to various and simultaneous process improvement initiatives to streamline processes, improve customer experience, and increase productivity.</li><li>Participate in audit-related activities</li></ul> Requirements: <ul><li>Bachelor’s degree in any business-related course or at least 10 years of candidate sourcing experience using online channels such as job boards, social media, and other professional networks.</li><li>Experience using applicant tracking systems, such as SmartRecruiters, Workday, Taleo, and other similar platforms.</li><li>Experience with sourcing techniques such as Boolean search or other relevant search principles</li><li>Exposure to global markets is preferred.</li><li>Intermediate proficiency in MS Office tools</li><li>Reporting and tracking experience</li><li>Excellent interpersonal and communication skills</li><li>Ability to work with a team and coordinate sourcing activities.</li><li>Agile and can work in a fast-paced environment.</li><li>Ability to effectively communicate and collaborate within a varied audience and internal and external customers. (Communication)</li><li>Ability to maintain good customer relationship with the ability to suggest ways to improve customer support customer experience (Customer Service)</li><li>Ability to be thorough and meticulous in completing assigned tasks and identifying errors, duplicates, &amp; discrepancies through defined methods. (Attention to Detail)</li><li>Ability to identify and resolve simple to moderate with the ability to provide resolution alternatives by following defined policies and procedures. (Problem Solving)</li></ul>

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>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 sop Jobs found

Quality Assurance Associate

QC Supervisor

Process Operator

Accounts Payable Associate

Talent Acquisition Lead

QC Chemist I

Laboratory Systems Analyst

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7 sop Jobs found

Quality Assurance Associate

QC Supervisor

Process Operator

Accounts Payable Associate

Talent Acquisition Lead

QC Chemist I

Laboratory Systems Analyst

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

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TALENT

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