Quality Specialist, Regulatory
MRP Solutions
Summary: The Quality Systems Specialist will manage internal ISO/Food Safety processes and schedule and support MRP Internal and External Audits under the direction of the Quality Assurance Manager. They are also responsible for administrative support to fulfill customer inquiries regarding compliance with applicable standards and regulations. Essential functions:
- Lead representative for customer audits. Host audits as scheduled and follow up on reporting of any corrective action(s) required as a result of observations during the audits.
- Manages corrective action program. Issues corrective actions, monitor and track progress, and ensure timely response, verification, and evaluation of effectiveness by process owners.
- Manages internal audit program. Define internal audit schedule to ensure the QMS and FSMS are effectively implemented and are performing as intended.
- Maintain ISO9001:2015 and FSSSC22000 Management Systems.
- Report issues and escalate to management as needed.
- In conjunction with the maintenance manager, manages the pest control program
- Understand applicable industry requirements.
- Bachelor's Degree
- 3+ years' experience working in a similar role (Quality/Food Safety focused position)
- Experience using Microsoft Office software (Word, Excel, Outlook, PowerPoint, etc.)
- Excellent listening skills along with highly effective written and verbal communication skills
- Able to prioritize tasks
- Understanding of CFR 21, GFSI, ISO, DMF, and other food/pharmaceutical standards and expectations.
- Monitor and verify activities to ensure that all maintenance work in the facility meets food safety standards in addition to quality standards.
- Comply with all company food safety and quality assurance procedures and complete documentation correctly.
- Ensure all work product contact surfaces are restored to sanitary condition after any job completion.
- Report incidents, and product or process failures that could impact food safety of manufactured product to your direct reports and submit a safety/food safety incident report.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality Specialist, Regulatory in Somerset, NJ vacancy
$32 per hour
...Job Description Job Description Title: Quality Specialist Location: Bridgewater, NJ Company: Fortune 100 Food & Beverage Manufacturing... ...) to full compliance to Quality, Food Safety and Regulatory requirements. This position is responsible for the creation...RegulatoryHourly pay$30 per hour
...Job Description Job Description Job Title: Quality Specialist Job Description The Quality Specialist acts as a guardian of quality... ...from idea to launch meet defined quality, food safety, and regulatory requirements. This role serves as the primary quality representative...RegulatoryFull timeContract workTemporary workWork at officeMonday to Friday- The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA... ...at CMO site. Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and...Regulatory
$70.35k - $87.94k
...consent or decline to our use of Google Analytics below.Quality Product Safety Specialist page is loaded## Quality Product Safety Specialistremote... ...improvement initiatives* Maintain accurate records for FDA and regulatory compliance* Interact cross-functionally to support...RegulatoryFor contractors- ...Approving Calibration and Maintenance forms. Perform Client's investigations. Review and approve calibration and maintenance work. Regulatory Responsibilities Maintains all required Corporate, Facilities and EHS training as required. Adheres to all safety procedures and...RegulatoryWork at office
$32 per hour
...Job Description Job Description Title: Quality Specialist - Project Lead Location: Bridgewater, NJ Company: Fortune 100 Food... ...order to ensure full compliance to quality, food safety, and regulatory requirements. What You'll Do: Be part of the Internal...RegulatoryHourly pay- ...have a job opening and exciting opportunity for a full-time Quality Specialist in our Edison, NJ location. The primary role of the... ...related meetings. Support external audits with customers, regulatory bodies, and third-party auditors and track audit findings with...RegulatoryFull timeTemporary workWork at officeLocal areaRemote workWork from home
- ...technical minds in personal care with over 50 years of combined experience in the industry. We are looking for a Quality Assurance & Regulatory Specialist. This individual will oversee all aspects of the facility to ensure that various departments are being compliant with...RegulatoryShift work
- Join a forward-thinking company as a Quality Assurance Specialist, where you will oversee critical quality processes in a dynamic environment.... ...ensuring compliance with GMP standards, and preparing for regulatory audits. You will play a vital role in maintaining product...Regulatory
- ...products. Job Description Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for...RegulatoryFull timeContract workFor subcontractorMonday to Friday
$33 per hour
...Adecco is assisting a local client recruiting for Quality Specialist Project Lead (Hybrid) opportunities in Bridgewater, NJ. This is an excellent... ...(I2L) and the client by embedding quality, food safety, and regulatory requirements into product and technology development. You...RegulatoryHourly payTemporary workLocal area- ...We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares... ..., between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge...RegulatoryFlexible hours
- ...Advancement Job Summary We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible... ...Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRS’s mission...RegulatoryWorldwide
- Quality Assurance (QA) Associate job at Strides. East Brunswick, NJ. Job Description Primary responsibilities of this role include the... ...of product returns. Assist during FDA inspections and local regulatory inspections at Strides’ US corporate office. Job-Specific Requirements...RegulatoryContract workWork at officeLocal area
$38 - $40 per hour
...Job Description Job Description Job Title: Quality Assurance Specialist Job Description We are seeking a motivated and detail-oriented... ...therapy, etc.) ~ Basic understanding of cGMP principles and regulatory requirements (FDA, EMA, ICH). ~ Familiarity with...RegulatoryContract workTemporary work- Merck & Co. is seeking a QA Shop Floor Specialist in Raritan, NJ for quality oversight during the production of CAR-T products in a cGMP cleanroom environment... ...include ensuring compliance with company and regulatory standards, reviewing documentation, and collaborating with...Regulatory
- WuXi Biologics is seeking a Senior QA Specialist I located in Cranbury Township, NJ, to handle quality assurance activities related to Drug Substance Manufacturing... ...tasks related to process compliance and regulatory adherence. The role requires extensive QA activities...Regulatory
- ...QA Shop Floor Specialist II Legend Biotech is a global biotechnology company dedicated... ...QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey... ...to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently...RegulatoryWork experience placementImmediate startWorldwideFlexible hoursWeekend workDay shift
$57.5k - $83.4k
...aspect of our business. Primary Purpose The Quality Assurance Specialist is responsible for ensuring consistent service quality by... ...and maintain current service records, decals, and regulatory compliance.Identify and report recurring service or materials...RegulatoryFull timeTemporary workPart timeSecond jobWork at officeLocal areaFlexible hours$75.97k - $99.71k
...Role Overview Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey . The QA... ...but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform...RegulatoryWork experience placementImmediate startWorldwideFlexible hoursWeekend work- ...America Job Description: DePuy Synthes is recruiting for a Quality/Compliance Analyst - Customer Service, located in New... ...Preferred: Coursework or concentration in Quality Management, Regulatory Affairs, or Operations. Experience and Skills Required:...RegulatoryWork experience placementWork at officeLocal areaImmediate startRemote work
- Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop... ...floor support for extended periods of time. Support regulatory inspections and audits as needed. Consistently perform...RegulatoryPermanent employmentFull timeFor contractorsLocal areaImmediate startFlexible hoursWeekend workDay shift
$61k - $90k
...Perform special investigations, audits and provide reporting for quality issues at our plants Participate in conducting field tests,... ...analysis within the plant Responsibilities The Field Quality Specialist will work closely with our trade and retail accounts to...For contractorsRemote workFlexible hours3 days per week- 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
- Elite Recruit LLC is seeking a Quality Control (QC) Manager in New Brunswick, NJ. The role involves overseeing quality control functions in a dietary supplement CDMO environment, ensuring compliance with FDA and cGMP standards. The ideal candidate will have 5+ years in...Regulatory
- An established industry player is seeking a Quality - Laboratory Instrumentation Support Technician to ensure compliance and accuracy... ..., and collaborating with the quality team to uphold GMP regulatory standards. This position requires a detail-oriented individual...Regulatory
- ...for pharma/healthcare applications by gathering business requirements, supporting testing activities, and ensuring adherence to regulatory standards and operational processes. Key Responsibilities Collaborate with stakeholders to gather and document business...Regulatory
- Johnson & Johnson MedTech is seeking a Senior Counsel, Regulatory Law, based in New Brunswick, NJ. The role involves providing legal counsel on regulatory and compliance issues related to innovative MedTech products. The ideal candidate will have a J.D. and at least 7...Regulatory
$137k - $140k
...seeking a Manager for their QC Lab in Piscataway, NJ. This role involves managing quality control activities to ensure timely delivery of materials for production and compliance with regulatory standards. The ideal candidate should have a Bachelor's degree in Pharmacy or...Regulatory- Bristol Myers Squibb is seeking a Logistics Support Specialist in New Brunswick, NJ to oversee domestic and global shipment logistics.... ...role involves coordinating international shipping documentation, regulatory compliance, and tracking shipment readiness. The ideal...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Specialist, Regulatory. Be the first to apply!
Related searches


