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| Job Category : | Management |
| Company Name: | Entegee |
| Position Name: | Quality Manager |
| Location : | Athens, OH |
| Job Description : | Job descriptionExperience in aseptic areas & sterile processing (preferably in sterile compounding operations)Bachelor’s in science, preferably in Microbiology and ChemistryMust have a good Microbiology backgroundManagement experienceOther experience such as validations, environmental monitoring, OOS investigations, CAPA, deviations, performing trainings, performing audits and general Quality Systems expertise will be helpfulWill be signing Doc’sResponsible for managing all aspects of Quality Assurance, including batch disposition and management of QA activities related to manufacturing and testing of drug product.This position is also responsible for Internal and External audits, Supplier Management, Environmental Monitoring, and training and mentoring of staff.Responsibilities: Lead and direct the site Quality Unit.Lead and facilitate site regulatory inspections, including Food and Drug Administration (FDA).Serve as the site’s primary contact for FDA, cGMP consultants, and customers regarding quality and regulatory compliance.Document review and batch disposition of drug product. Review and approve batch records, including change controls, investigations (deviations, out-of-specification (OOS)/out-of-trend (OOT)), and analytical data.Review and approve complaints. Obtain corrective and preventive actions (CAPA).Serve as the subject matter expert in Microbiology, including environmental monitoring, sterility, endotoxin and bioburden testing.Direct and maintain the environmental and personnel monitoring programs.Responsible for performing impact assessment related to batch disposition.Review and approve test methods (i.e. sterility), method validation protocols (i.e. aseptic process simulations) and reports, stability protocols and reports.Review and approve quality agreements, SOPs, and specifications.Review and approval of manufacturing process validation protocols and reports.Direct and maintain the self-inspection/internal audit program.Lead and maintain the Supplier Management program.Lead, train and mentor in continuous improvement initiatives.Essential Duties: Ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.Support departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of quality operations.Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork.Interpret Regulatory Authority regulations, guidelines and policies.Communicate and ensure compliance with Quality objectives, policies and proceduresentegee.comThis message is intended only for the designated recipient(s). It may contain confidential or proprietary information and may be subject to other contractual or confidentiality protection. If you are not a designated recipient, you may not review, copy or distribute this message. If you receive this message in error, please notify the sender by reply email and delete this message.Entegee, part of The Adecco Group North America headquartered at 10151 Deerwood Park Boulevard, Building 200, Suite 400, Jacksonville, Florida, 32256, is committed to data privacy compliance. To learn more about how we collect and process personal information, please read our General Privacy Policy located on the website above.Job Types: Full-time, ContractPay: From $1.00 per yearBenefits:Dental insuranceHealth insuranceVision insuranceSchedule:8 hour shiftMonday to FridayAbility to commute/relocate:Athens, OH: Reliably commute or planning to relocate before starting work (Preferred)Experience:ISO 9001: 1 year (Preferred)Quality Assurance Managers: 1 year (Preferred)Work Location: One location |
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