Quality Assurance Expert 1
1 month ago
Job Summary
Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance.
Support the site's maintenance, development, and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control.
Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems.
Support the site's compliance activities through regulatory recordkeeping and reporting.
Key Responsibilities
- Process Improvement
- Actively participate in the development, implementation, and improvement of Quality Systems.
- Routinely support and recommend ongoing process improvements within the department, ensuring efficient and value-added processes.
- Lead and participate in work with Production, QC, Procurement, Packaging, Maintenance, Customer Service, and Marketing to resolve issues and failures with site products and equipment. Work closely with the site departments to implement process changes based on investigation conclusions.
- Oversee Trackwise system and aid end users to ensure appropriate entries are made and resolution is achieved in a timely manner.
- Present various quality system training topics to site personnel when necessary.
- Identify opportunities for process improvement.
- Ensure Acceptable Product and Process Consistency
- Serve as a primary reviewer of executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.
- Assist in writing, reviewing, or approving GMP Operating Procedures, Validation Protocols/Reports, Master Production Records, Specifications, and other documents for GMP products.
- Support the Site's Compliance Activities
- Ensure reports are complete and accurate for HR4You, Trackwise, Mango, and site quality metrics.
- Ensure appropriate site Quality Assurance personnel are trained as backup for systems role.
- Facilitate training of other site personnel as required.
- Follow all safety and quality requirements to complete assigned work.
- Bachelor's degree in Chemistry, Biology, or other Life Science required with 2 or more years GMP-related experience in the chemical, specialty chemical, and/or pharmaceutical industry.
Education: Bachelors Degree
-
Quality Assurance Expert 1
1 month ago
Miamisburg, United States Compunnel Full timeJob Summary Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site’s maintenance, development, and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all...
-
Quality Assurance Specialist with GMP Expertise
4 weeks ago
Miamisburg, Ohio, United States Randstad Life Sciences Full timeAbout the RoleJoin a dynamic team at Randstad Life Sciences as a Quality Assurance Expert.We are seeking a highly skilled professional to support our site's quality systems, ensuring compliance with regulatory requirements and industry standards. The ideal candidate will possess a strong background in GMP (Good Manufacturing Practice) principles and...
-
Quality Assurance Specialist
1 week ago
Miamisburg, Ohio, United States Randstad Life Sciences Full timeJob OverviewAs a Quality Assurance Specialist at Randstad Life Sciences, you will play a critical role in ensuring the quality and compliance of our products. This is an exciting opportunity to join a dynamic team and contribute to the success of our company.Key Responsibilities- Support GMP production by performing batch record issuance, review, correction,...
-
Highly Skilled Quality Assurance Specialist
1 month ago
Miamisburg, Ohio, United States Experis Full timeWe are seeking a Highly Skilled Quality Assurance Specialist to support our laboratory team in the life sciences industry.**Job Summary:**Evaluate stable isotope products, raw materials and in-process materials according to established procedures.Safely perform operations to meet quality expectations.Perform multi-disciplined, established assays and/or unit...
-
Miamisburg, United States Indotronix International Corporation Full timeIndotronix is seeking a Senior Quality Assurance Specialist in the Pittsburgh(PA) OR Cleveland(OH) location Position Title: Senior Quality Assurance Specialist Position Location: 1) Pittsburgh(PA) 2) Cleveland(OH) Ability to work remotely: Hybrid - 3 days in office, 2 remotely Duration: Contract to hire Roles and Responsibilities: • Daily stand-up...
-
Speech and Language Expert for Kids
7 days ago
Miamisburg, Ohio, United States Dayton Children's Full timeAbout the Role:The Speech and Language Expert for Kids will join the multidisciplinary team at Dayton Children's to provide high-quality speech-language services to pediatric patients. This role requires expertise in pediatric assessment and intervention strategies, as well as excellent communication skills to collaborate with caregivers and other healthcare...
-
Senior Quality Control Engineer
7 days ago
Miamisburg, Ohio, United States Aeroseal Full timeAbout Us">Aeroseal is a leader in the HVAC industry, committed to pioneering solutions that address critical challenges in residential, commercial, and industrial settings.">Job Summary">We are seeking a skilled Senior Quality Control Engineer to join our team. The successful candidate will be responsible for developing, implementing, and maintaining quality...
-
Product Quality Assurance Engineer
7 days ago
Miamisburg, Ohio, United States Avery Dennison Full timeJob DescriptionAvery Dennison is a leading provider of innovative solutions for the labeling and packaging industries. We're seeking a skilled Test Engineering Intern to join our team in North America.In this role, you will assist in the development and execution of test plans, procedures, and test cases for hardware systems, including RFID and IoT devices....
-
Quality Management Specialist
1 week ago
Miamisburg, Ohio, United States Textum Full timeAt Textum, we're seeking a seasoned Quality Manager to lead our Dayton, OH composite manufacturing operation in achieving exceptional quality standards.Job DescriptionThe primary responsibility of this role is to oversee the implementation and deployment of our Quality Plan in conjunction with the plant management team. This includes ensuring product...
-
Senior Quality Control Professional
1 week ago
Miamisburg, Ohio, United States Randstad Life Sciences Full timeJob SummaryWe are seeking a Senior Quality Control Professional to join our team at Randstad Life Sciences. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products.Duties and Responsibilities- Serve as a primary reviewer of executed GMP batch documentation to determine whether process and...
-
GMP Compliance Expert
2 weeks ago
Miamisburg, Ohio, United States Randstad Life Sciences Full timeJob DescriptionWe are seeking a seasoned Quality Assurance Specialist to join our team at Randstad Life Sciences. As a key member of our QA department, you will play a crucial role in ensuring the quality and integrity of our products.About the JobThis is a challenging and rewarding opportunity for a motivated individual who is passionate about delivering...
-
Cybersecurity Director
4 weeks ago
Miamisburg, Ohio, United States Wilmerhale Full timeOverviewWilmerHale is a leading international law firm with 1,000 lawyers across 12 offices in the United States, Europe, and Asia. Our team provides exceptional legal services to clients worldwide.
-
Miamisburg, Ohio, United States Dayton Children's Full timeJob Overview:The Children's Speech Language Pathologist Leader will lead the speech-language team at Dayton Children's, providing clinical leadership and expert guidance in pediatric speech-language services. This role requires strong leadership skills, expertise in pediatric assessment and intervention, and excellent communication skills to collaborate with...
-
Structural Fabrication Specialist
2 weeks ago
Miamisburg, Ohio, United States Advantic Building Group Full timeJob SummaryWe are seeking an experienced Carpentry Expert to join our team at Advantic Building Group. This role involves fabricating and assembling fiberglass structures using standard carpentry tools and techniques to specified standards and level of craftsmanship.The ideal candidate will possess a high school diploma or equivalent, with 5-7 years of...
-
Hospice Chaplain Lead
2 weeks ago
Miamisburg, Ohio, United States Affinity Care of Ohio Full timeJob Summary:The Affinity Care of Ohio organization is committed to delivering exceptional care to patients and families, with a focus on meeting their unique spiritual needs. We are seeking a dedicated and compassionate Hospice Chaplain Lead to join our team, providing leadership and guidance in spiritual care services.Key Responsibilities:1. Supervise and...
-
RN Infection Control Specialist
2 months ago
Miamisburg, United States Kettering Medical Center Network Full timeOverview Kettering Health is a not-for-profit system of 13 medical centers and more than 120 outpatient facilities serving southwest Ohio. We are committed to transforming the health care experience with high-quality care for every stage of life. Our service-oriented mission is in action every day, whether it's by providing care in our facilities, training...
-
RN Healthcare Safety Expert
3 weeks ago
Miamisburg, Ohio, United States Kettering Medical Center Network Full timeAbout Kettering Health NetworkKettering Health Network is a not-for-profit system of 13 medical centers and over 120 outpatient facilities serving southwest Ohio. Our mission is to deliver high-quality care for every stage of life, driven by our commitment to innovation, caring, competence, and collaboration.We are proud to have been recognized as a leader...
-
Spiritual Care Specialist
2 weeks ago
Miamisburg, Ohio, United States Affinity Care of Ohio Full timeJob Title: Spiritual Care SpecialistThe Affinity Care of Ohio organization is seeking a highly skilled and compassionate Spiritual Care Specialist to join our interdisciplinary team. This role is responsible for providing spiritual care services to patients and families/caregivers, ensuring their unique needs are met in a timely manner.Key...
-
Speech Pathologist
4 weeks ago
Miamisburg, United States Dayton Children's Full timeFacility: Dayton Children's - South CampusDepartment: Speech Language PathologySchedule: Full timeHours: 40Job Details: The Speech/Language pathologist demonstrates competency in pediatric assessment and intervention strategies and is able to carry out a thorough evaluation and implement an appropriate treatment plan with measurable goals/objectives. They...
-
Production Leadership Specialist
2 weeks ago
Miamisburg, Ohio, United States Beneficial Talent Source Full timeJob DescriptionThe Production Leadership Specialist will lead a team of Assembly Technicians at Beneficial Talent Source. This role requires strong leadership and technical skills, with the ability to motivate and develop a high-performance team. Key responsibilities include process optimization, team management, and quality assurance.Key...