MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager / GMP Expert. As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.
Responsibilities : Lead a team that manages specific quality management systems and processes such as deviation, CAPA, change control, training, audits, complaint management, supplier quality, document control, validation, and data integrityEnsure that departments responsible for products meet quality standards and performance goals of MilliporeSigmaEnsure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systemsSupport the site’s compliance activities through accurate regulatory recordkeeping and reportingManage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMPDrive risk reduction programs and ensure application of risk management and sound root cause analysisSupport the site’s regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.
Who You Are : Minimum Qualifications : Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or other Science field 5+ years experience with ISO 9001 and GMP requirements in a quality role inclusive of 2+ years experience in a leadership positionExperience in a chemical, specialty chemical and / or pharmaceutical industry Preferred Qualifications : 8+ years of experience with ISO 9001 and GMP requirements in a quality role in a chemical, specialty chemical and / or pharmaceutical industry3+ years of experience with increasing responsibilities as a people managerExperience with quality management systems such as Trackwise, electronic document management system, etc.
Experience with customer audits and regulatory inspections
Quality Assurance Manager/GMP Expert
As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies. Who You Are: Minimum Qualifications: Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or ot...
Quality Assurance Manager
Collaborate with the Plant Manager and Sanitation Manager to ensure proper housekeeping and maintenance of facilities, equipment, and grounds. Conduct pre-shipment reviews, CCPs, validation studies, and report deficiencies for GMPs, HACCP, and SSOPs. Knowledge of quality control processes related to...
Quality Assurance Manager
The Quality Assistant assesses and reviews physician documentation and coding and assist in maximizing healthcare performance and service in various Quality reporting components. UDS, PCMH, Optum, CPC, Quality grants, HEDIS, and improvement projects). Submit required documentation to receive quality...
Quality Assurance Manager
Collaborate with the Plant Manager and Sanitation Manager to ensure proper housekeeping and maintenance of facilities, equipment, and grounds. Conduct pre-shipment reviews, CCPs, validation studies, and report deficiencies for GMPs, HACCP, and SSOPs. Knowledge of quality control processes related to...
Manager Quality Assurance
Individual in this position must be capable of engaging other business units in development and standardization of quality manuals, policies, procedures, audit standards and Quality Key Performance Indicators. Adhere to safe work practices, follow GMP’s, maintain sanitary conditions and ensure that ...
Quality Engineer
In this role, the Quality Engineer will work closely with the Operations and Quality Teams to understand and analyze issues for a quality performance dashboard. Kelly Engineering is hiring for a Quality Engineer to step in at our client’s manufacturing site and hit the ground running. Develop, evalu...
Quality Control Manager
Note welders mark requiring corrective work on the quality control sheet. ...
Project Manager
As the Project Manager for the $2M CQV project, you will be responsible for planning, executing, and closing the project according to strict deadlines and within budget. This Project Manager needs to be highly skilled at managing multiple complex projects relating to commissioning, qualifying, and v...
Project Manager
Develop and maintain project plans, timelines, and resource allocation to effectively manage project schedules and meet project milestones. Position Title: Project Manager - Engineering. Lead and manage complex projects, ensuring timely delivery of client deliverables, adherence to contract requirem...
Quality Process Engineer
Applicant will also be responsible for root cause analysis and helping to develop actions to resolve manufacturing and quality issues. Ensure delivered products are compliant with quality planning models and are manufactured in compliance with standards. Work to ensure quality and productivity perfo...