Quality Investigations Specialist: CAPA & Root Cause
Merck
Merck & Co. is seeking an NOI Investigations Specialist to ensure product quality, compliance and patient safety by conducting investigations into quality events that may affect manufacturing, release, storage or shelf life. You will independently gather and evaluate data, identify root causes and develop CAPAs, write investigation reports, and communicate findings to regulators and auditors, while adhering to GMP and company policies. #J-18808-Ljbffr Merck & Co.
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- ...DEPARTMENT: QA REPORTS TO: Quality Manager POSITION DESCRIPTION: TheQuality Support Specialistis... ...as well as managing/writing any investigations that may be a result of those events.... ...with investigation writing, including root cause analysis and report writing. Strong organizational...SuggestedLocal areaFlexible hours
$15.92 per hour
...opportunity for a full-time Quality Specialist in our Edison, NJ location.... ...issues. Support root cause analysis efforts to help develop... ...corrective and preventive actions (CAPA). Act as liaison with... ...regarding quality issues, investigations, and corrective actions....SuggestedHourly payFull timeTemporary workWork at officeLocal areaRemote workWork from homeShift workDay shift$94k - $170k
...merit. Job Function: Quality Job Sub Function: Quality... ...two Quality Assurance Investigation Specialist III to join our QA team located... ...leads robustness of NC/CAPA investigations and approvals... ...ensuring timely triage, thorough root-cause analysis, and effective...SuggestedFull timeLocal areaImmediate startMonday to FridayShift workDay shift- ...are seeking an experienced Quality Assurance Specialist to join our team. In this... ...Deviation Management, CAPA, Change Control, Training,... ...regulatory documentation. 3. Investigations & Deviation Management... ...customer complaints ~ Perform root cause analysis (RCA), risk...SuggestedWorldwide
- ...Job Description Role: Sr. Quality Assurance Engineer. 100% onsite... ...candidates who have owned manufacturing investigations end to end, not supported them.... ..., not "assisted with " CAPA management including effectiveness checks Root cause analysis with named methodology...Worldwide
- ...cross-functional virtual plant team, this quality manager provides quality oversight of... ...requirements Evaluate external quality complaint investigations provided by CMOs Ensure maintenance of... ...actions and/or preventive actions (CAPA) and use of risk assessments Able to...Contract workWork at officeFlexible hours
- Amneal is seeking a Quality Assurance Specialist in New Jersey to ensure products and processes meet... ...standards through validation, investigations, and continuous improvement initiatives... ...change control, IQ/OQ/PQ execution, root-cause analysis of customer #J-18808-...
- ...transformation and product development rooted in digital strategy, experience design,... ...ecommerce, and education. Must have's: 1) quality assurance mindset for computer system validation... ..., such as Data Integrity Governance, Investigations, Global Quality Headquarters Training...
- ...Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes... ..., candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate...Full timeContract workFor subcontractorMonday to Friday
$85k - $100k
Description The Quality Assurance Specialist is responsible for ensuring products and processes meet... ...validation activities, quality investigations, complaint handling, process monitoring... ...teams to drive compliance, root cause analysis, process validation, and the...Flexible hours$83.71k - $109.87k
...seeking a QA Laboratory Compliance Specialist III as part of the Quality team based in Raritan, NJ .... ...Micro, QC Lab Services and QC Investigations. Key Responsibilities Work... ...Functional Area Owners) to align on root cause, corrections, and CAPAs. Provide guidance to QC in...Permanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaImmediate startFlexible hours- ...for retrieving data and other functions related to Production Quality. Work with customers for confirming information related to new... ...including but not limited to FDA, ISO, global standards, etc. Investigates nonconformances/concerns related to customer complaints, reworks...
$20.6 per hour
...Quality Control Specialist It's more than a job As part of the Contract Logistics team at Kuehne+Nagel, you will play a key role in... ...document non-conformances, initiate reports, and follow up on CAPA actions Coordinate with warehouse teams to resolve...Hourly payContract workSeasonal workWork at officeLocal area- ...MRP Solutions, a plastic cap manufacturer, is seeking a Quality Support Specialist to own investigations of product and process deviations and ensure compliance with Food Safety guidelines, GMPs and SOPs. The role interacts with Operations, Continuous Improvement and...
$70k - $75k
...access to important medicines. The Quality Assurance Specialist is a regular employee in a full-time... ...releasing material, reviewing deviations, CAPAs, chance controls, validation/... ...documentation to include SOPs, deviation/investigation reports, equipment/system...Full timeWork at officeLocal areaFlexible hours- ...troubleshooting HPLC, SDS‑PAGE, cell‑based bioassays, capillary electrophoresis, and ELISA Supporting Out of Specification investigations, deviations, and CAPA plans Authoring and reviewing SOPs, technical documents, and reports Collaborating cross‑functionally to advance...
- ...-PAGE, ELISA, and cell-based bioassays is essential. The role requires collaboration across departments to drive investigations, CAPA, and process improvements, with a focus on ensuring product quality and regulatory compliance. #J-18808-Ljbffr Kashiv BioSciences, LLC
$96.8k - $137k
...all.About the RoleAt Colgate-Palmolive, we are transforming our Quality organization to be proactive, digital-first, and AI-ready. To... ...data foundation. We are seeking a Digital Quality Systems Specialist - Governance, Analytics and Automation to serve as a vital custodian...Hourly payLocal areaRelocation$40 - $48 per hour
...Piper Companies is currently looking for an experienced Quality Control Specialist in Branchburg, New Jersey (NJ) to work for a... ...accordance with cGMP requirements Perform OOS/ Deviation investigations and carry out experiments in support of these investigations...$49.5k - $82.5k
...have an opportunity to contribute to the company's success. As a Quality Analyst within PNC's TM Operations Production Support... ...quality analysis; identifies systemic issues, facilitates effective root cause analysis and corrective actions. Provides conclusions and recommendations...Full timeTemporary workPart timeWork experience placementWork at officeRemote workMonday to Friday- AB Corporate in New Jersey is seeking a Quality Assurance/Specifications Specialist to prepare fill and assembly specifications and update them in the specification system, ensuring BOM alignment and material accuracy. You will coordinate with Customer Project Management...
- A quality assurance firm located in Piscataway, NJ is seeking a Quality Assurance Specialist to perform inspections and testing on finished goods and components. The role involves maintaining accurate records and assisting in the upkeep of laboratory equipment. Ideal candidates...Contract work
$75.97k - $99.71k
...Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of... ...driving compliance. Support Investigations team by providing quality and... ...at any time with or without cause or notice by the employee or...Permanent employmentFull timeContract workTemporary workWork experience placementLocal areaImmediate startWorldwideFlexible hoursWeekend workAfternoon shift- ...Management Program and collaborates with cross-functional teams to onboard and sustain suppliers. You will handle CAPA, audits, risk assessments, and quality agreements in a GMP environment. The position requires strong influencing skills and data-based decisions, with...
$75.97k - $99.71k
...Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan,... ...proactively driving compliance. Support Investigations team by providing quality and... ...at any time with or without cause or notice by the employee or the company...Work experience placementImmediate startWorldwideFlexible hoursWeekend work$32.28 per hour
...Our client, a leader in the food industry, is seeking a Quality Specialist to join their team. As a Quality Specialist, you will be part of the Quality Assurance department supporting food safety initiatives and compliance efforts. The ideal candidate will demonstrate...Permanent employmentTemporary workFlexible hoursShift work- ...The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible for managing the change control process, creating and updating...Contract work
$32 per hour
...Quality Specialist Guardian of Quality and Compliance by Design following the quality requirements and deliverables for Food Safety initiatives in raw material specifications (mainly RMPS and testing specifications) to full compliance to Quality, Food Safety and Regulatory...Hourly pay- ...participants for Legend's Manufacturing/Quality Management, Leadership Development Program... ...potential professionals early in their careers. Rooted in our commitment to cultivating... ...be terminated at any time with or without cause or notice by the employee or the company....Permanent employmentFull timeFor contractorsLocal areaWorldwide
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