{"schemaVersion":"jobsearcher.job.v1","id":"e494e100bc0a4e144192aab5","url":"https://jobsearcher.com/jobs/e494e100bc0a4e144192aab5","canonicalUrl":"https://jobsearcher.com/jobs/e494e100bc0a4e144192aab5","title":"Quality Control Lead - 2nd Shift","description":"The Quality Control Lead, Production ensures compliance in company programs to maintain adherence to procedures, processes, and cGMP standards. The QC Lead, Production provides cGMP oversight, process leadership, and quality-related guidance on the production floor regarding documentation, inspection, and manufacturing/packaging processes.\n\nESSENTIAL DUTIES AND RESPONSIBILITIES\n\nPerform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.\n\nDetermine proper in-process test standards and assure compliance to established standards.\n\nPerform sampling and inspection of bulk drug and excipients.\n\nSet aside and maintain customer or Sharp Clinical Services reserve samples.\n\nProvide guidance to QC production team on inspection techniques, good documentation practices (GDP), and resolving any technical questions which may arise on shift.\n\nPerform physical testing using basic inspection instrumentation.\n\nPerform daily verification activities (temperature, humidity, weight on balances, etc.).\n\nChange status of material, GMP areas, equipment and utensils.\n\nDetermine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.\n\nPerform pre-production line clearance to the GMP area prior to the initiation of production.\n\nPerform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.\n\nPerform verification of cleaned GMP areas, equipment and utensils.\n\nPerform inspections thoroughly and with an exceptional level of detail in regard to quality.\n\nExcel in operating equipment.\n\nIdentify and implement process changes that enhance efficiency and compliance of routine work.\n\nAuthor and revise SOPs and procedures.\n\nProvide thorough and effective training to QC trainees on cGMP, SOPs, BRs and quality events.\n\nProvide solutions or insight to other QC personnel regarding routine tasks.\n\nEnsure testing is in adherence to current procedures and sampling plans.\n\nEnsure compliance with cGMP and Sharp Clinical Services SOPs during clinical and commercial supply production.\n\nEnsure employees and visitors comply with applicable Sharp Clinical Services, Inc. SOPs.\n\nAssist in writing or executing change controls, CAPAs, investigations, technical problems, procedures, complaints and non-conformances which are approved in a timely manner.\n\nMaintain accurate, detailed records of work performed.\n\nProvide timely communication of quality or cGMP issues to supervisor.\n\nWork with internal staff to meet scheduled requirements in a timely manner.\n\nRemain accountable for maintaining a clean, orderly and safe work environment.\n\nAdhere to set safety standards.\n\nParticipate actively in routine meetings.\n\nAchieve expected performance measures.\n\nCommunicate effectively and professionally.\n\nDemonstrate strong interpersonal skills, is approachable, engaged, presentable, and helps others.\n\nPerform other duties as assigned.\n\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.\n\nQUALIFICATIONS\n\nHigh School Diploma, Bachelors’ Degree or equivalent in related field preferred.\n\nPreferred 5 years of prior experience in pharmaceutical or biotech manufacturing/packaging (a Quality Control, Quality Assurance, Manufacturing or Compliance role is preferred).\n\nAbility to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.\n\nExcellent oral and written communication is required to communicate with the team, peers, management and external contacts.\n\nAbility to interpret and implement cGMPs, FDA & DEA Regulations and CFRs.\n\nStrong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.\n\nPHYSICAL DEMANDS\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.\n\nWhile performing the duties of this job, the employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms and talk or hear. Employee is occasionally required to walk and sit. The employee must occasionally lift and/or move up to 30 pounds.\n\nSpecific vision abilities required by this job include close, distance, ability to adjust focus, color and depth perception.\n\nENVIRONMENTAL CONDITIONS\nWhile performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts. The employee is required to wear PPE such as a lab coat, safety glasses, and on occasion, an N-95 and PAPR (respirator). The noise level in the work environment is usually moderate\n\n#J-18808-Ljbffr","company":"Sharp Packaging Services","rawCompany":"sharp packaging services","city":"South Bethlehem","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-09-29T03:27:44.770Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"51-9061.00","title":"Inspectors, Testers, Sorters, Samplers, and Weighers","slug":"inspectors-testers-sorters-samplers-and-weighers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Control Lead - 2nd Shift","description":"The Quality Control Lead, Production ensures compliance in company programs to maintain adherence to procedures, processes, and cGMP standards. The QC Lead, Production provides cGMP oversight, process leadership, and quality-related guidance on the production floor regarding documentation, inspection, and manufacturing/packaging processes.\n\nESSENTIAL DUTIES AND RESPONSIBILITIES\n\nPerform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.\n\nDetermine proper in-process test standards and assure compliance to established standards.\n\nPerform sampling and inspection of bulk drug and excipients.\n\nSet aside and maintain customer or Sharp Clinical Services reserve samples.\n\nProvide guidance to QC production team on inspection techniques, good documentation practices (GDP), and resolving any technical questions which may arise on shift.\n\nPerform physical testing using basic inspection instrumentation.\n\nPerform daily verification activities (temperature, humidity, weight on balances, etc.).\n\nChange status of material, GMP areas, equipment and utensils.\n\nDetermine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.\n\nPerform pre-production line clearance to the GMP area prior to the initiation of production.\n\nPerform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.\n\nPerform verification of cleaned GMP areas, equipment and utensils.\n\nPerform inspections thoroughly and with an exceptional level of detail in regard to quality.\n\nExcel in operating equipment.\n\nIdentify and implement process changes that enhance efficiency and compliance of routine work.\n\nAuthor and revise SOPs and procedures.\n\nProvide thorough and effective training to QC trainees on cGMP, SOPs, BRs and quality events.\n\nProvide solutions or insight to other QC personnel regarding routine tasks.\n\nEnsure testing is in adherence to current procedures and sampling plans.\n\nEnsure compliance with cGMP and Sharp Clinical Services SOPs during clinical and commercial supply production.\n\nEnsure employees and visitors comply with applicable Sharp Clinical Services, Inc. SOPs.\n\nAssist in writing or executing change controls, CAPAs, investigations, technical problems, procedures, complaints and non-conformances which are approved in a timely manner.\n\nMaintain accurate, detailed records of work performed.\n\nProvide timely communication of quality or cGMP issues to supervisor.\n\nWork with internal staff to meet scheduled requirements in a timely manner.\n\nRemain accountable for maintaining a clean, orderly and safe work environment.\n\nAdhere to set safety standards.\n\nParticipate actively in routine meetings.\n\nAchieve expected performance measures.\n\nCommunicate effectively and professionally.\n\nDemonstrate strong interpersonal skills, is approachable, engaged, presentable, and helps others.\n\nPerform other duties as assigned.\n\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.\n\nQUALIFICATIONS\n\nHigh School Diploma, Bachelors’ Degree or equivalent in related field preferred.\n\nPreferred 5 years of prior experience in pharmaceutical or biotech manufacturing/packaging (a Quality Control, Quality Assurance, Manufacturing or Compliance role is preferred).\n\nAbility to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.\n\nExcellent oral and written communication is required to communicate with the team, peers, management and external contacts.\n\nAbility to interpret and implement cGMPs, FDA & DEA Regulations and CFRs.\n\nStrong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.\n\nPHYSICAL DEMANDS\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.\n\nWhile performing the duties of this job, the employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms and talk or hear. Employee is occasionally required to walk and sit. The employee must occasionally lift and/or move up to 30 pounds.\n\nSpecific vision abilities required by this job include close, distance, ability to adjust focus, color and depth perception.\n\nENVIRONMENTAL CONDITIONS\nWhile performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts. The employee is required to wear PPE such as a lab coat, safety glasses, and on occasion, an N-95 and PAPR (respirator). The noise level in the work environment is usually moderate\n\n#J-18808-Ljbffr","datePosted":"2026-09-29T03:27:44.770Z","dateModified":"2026-09-29T03:27:44.770Z","hiringOrganization":{"@type":"Organization","name":"Sharp Packaging Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"South Bethlehem","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e494e100bc0a4e144192aab5"},"url":"https://jobsearcher.com/jobs/e494e100bc0a4e144192aab5"}}