Quality Assurance Specialist
3 days ago
The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.
This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.
The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.
Key Responsibilities:
- Prepare Quality System documents and reports as needed for Rocklin site metrics and management review.
- Ensure submitted documents comply with company procedures, regulatory requirements, and the quality manual.
- Review and audit Device History Files (DHFs) and technical files, including stability reports, risk management plans, product composition, performance evaluation, and safety reports.
- Assess data and records for proper documentation and record-keeping practices.
- Coordinate file uploads to EDMS; act as technical approver for quality documents.
- Write, revise, and review Standard Operating Procedures (SOPs).
- Support internal/external audits and maintain knowledge of SOPs and policies.
- Provide training, follow quality system requirements, and ensure compliance with regulatory standards (cGMP, ISO 13485, IVDD/IVDR).
- Collaborate with stakeholders to address quality issues and offer improvement suggestions.
Requirements:
- Preferred: Bachelor's degree in any life science, GMP, Pharma industry experience
- At least 1 year of experience
-
Support Desk Quality Assurance Lead
1 week ago
Rocklin, California, United States TalentBurst Full timeJob Title: Support Desk Quality Assurance LeadWe are seeking a highly skilled Support Desk Quality Assurance Lead to play a critical role in ensuring high standards of service and efficiency within our support desk operations.About the RoleThe Support Desk Quality Assurance Lead is responsible for reviewing and analyzing customer feedback, tracking and...
-
IT Specialist
4 days ago
Rocklin, California, United States Crimson Industries Full timeAbout Crimson IndustriesCrimson Industries is a leading service agency with diverse tasks in risk management and offices in various locations. Our top priority is to provide innovative solutions for our clients and partners. We are seeking a highly skilled IT Specialist to join our team.Job SummaryWe are looking for a talented IT Specialist to take on the...
-
IT Support Specialist
9 hours ago
Rocklin, California, United States TalentBurst Full timeJob Title: Support Desk Quality Assurance LeadLocation: RemoteDepartment: Stores Service DeskJob Summary:The Support Desk Quality Assurance Lead plays a crucial role in ensuring high standards of service and efficiency within the support desk operations at TalentBurst. This position involves reviewing and analyzing customer feedback, tracking and trending...
-
Instructional Support Specialist
7 days ago
Rocklin, California, United States Rocklin Unified School District Full timeAbout the EmployerThe Rocklin Unified School District is a leading educational institution committed to providing a well-rounded education to its students. Our mission is to foster a culture of innovation, collaboration, and high expectations, where students can thrive intellectually and develop unique strengths to pursue their personal ambitions.Key...
-
Prep Culinary Specialist
2 weeks ago
Rocklin, California, United States Yummy Poké Full timeJob DescriptionYummy Poke is seeking a dedicated culinary specialist to enhance our kitchen operations. We are committed to providing fresh and healthy meals to our customers. Key Responsibilities: Efficiently cut and process fresh fish, including Salmon, Tuna, and Albacore, into precise portions.Adhere to established recipes while preparing daily stock of...
-
Rocklin, California, United States Caltcm Full timeCustodial Specialist for Senior Living CommunityCompany: CaltcmPosition Type: FULL-TIME (Sunday thru Thursday, 7am to 3pm)At Caltcm, our Custodial Specialist plays a vital role in maintaining a clean and welcoming environment for our residents, their families, and our staff. This position is not just about cleaning; it’s about enhancing the quality of life...
-
Custodial Specialist for Senior Living Community
2 weeks ago
Rocklin, California, United States Caltcm Full timeCustodial Specialist for Senior Living CommunityCompany: CaltcmPosition Type: FULL-TIME (Sunday thru Thursday, 7am to 3pm)At Caltcm, our Custodial Specialist plays a vital role in maintaining a clean and welcoming atmosphere for our residents, their families, and our team members. We take pride in enhancing the quality of life for seniors, ensuring their...
-
Rocklin, California, United States Caltcm Full timeCustodial Specialist for Senior Living CommunityCompany: CaltcmPosition Type: FULL-TIME (Sunday thru Thursday, 7am to 3pm)At Caltcm, our Custodial Specialist plays a vital role in maintaining a clean and welcoming atmosphere for our residents, their families, and our team members. This position is essential in ensuring that we uphold the highest standards of...
-
ERP Production Specialist
5 days ago
Rocklin, California, United States Ledgent Technology Full timeJob SummaryWe are seeking a highly skilled Production Planning Specialist to join our team at Ledgent Technology. As a key member of our production team, you will be responsible for ensuring the smooth operation of our production processes.Key ResponsibilitiesSchedule Production Materials: Plan and schedule the usage of production materials to optimize...
-
Utilization Review Specialist
2 weeks ago
Rocklin, California, United States EK Health Services Inc Full timeJob OverviewAre you passionate about healthcare and interested in transitioning from direct patient care to a more analytical role? This position offers a unique opportunity to leverage your clinical expertise in a non-clinical environment.As a Utilization Review Specialist at EK Health Services Inc, you will be instrumental in evaluating the necessity and...
-
Sales Route Specialist
2 weeks ago
Rocklin, California, United States Flowers Foods Full timeFRESH. FORWARD. FLOWERS.Flowers Foods, Inc (NYSE: FLO) is dedicated to more than just baking; we are committed to creating moments of happiness with every delightful bite. With impressive sales figures, totaling $4.8 billion, we stand as one of the foremost producers of packaged bakery goods in the United States, infusing passion into every product. Our...
-
Utilization Review Specialist
2 weeks ago
Rocklin, California, United States EK Health Services Inc Full timeJob OverviewAre you looking to transition from direct patient care to a more analytical role in healthcare? This opportunity is perfect for those with a background in nursing or physical therapy who wish to apply their clinical expertise in a non-clinical environment.As a Utilization Review Specialist at EK Health Services Inc, you will be instrumental in...
-
Lead Stretching Specialist
2 weeks ago
Rocklin, California, United States StretchLab Twelve Bridges Full timePosition OverviewStretchLab Twelve Bridges is on the lookout for a dedicated health and fitness expert with aspirations for leadership to oversee our team of stretching professionals, known as Flexologists. This role presents a unique opportunity to advance your career in a rapidly growing sector of the fitness industry.Key ResponsibilitiesYour primary...
-
Sales Route Specialist
2 weeks ago
Rocklin, California, United States Flowers Foods Full timeFRESH. FORWARD. FLOWERS. Flowers Foods, Inc. (NYSE:FLO) is dedicated to more than just baking; we are about creating moments of happiness with every delightful bite. As a prominent player in the packaged bakery goods sector in the United States, with significant sales, Flowers Foods embodies a passion for quality. Our diverse range of products, from the...
-
Healthcare Utilization Review Specialist
2 weeks ago
Rocklin, California, United States EK Health Services Full timeJob Type: Full-timeDescription: Are you eager to transition from direct patient care to a more analytical role within the healthcare sector? This is an excellent opportunity to utilize your Nursing or Physical Therapist credentials in a non-clinical environment. If you have a keen interest in healthcare and enjoy analyzing medical data, consider a career as...
-
Laboratory Production Specialist
2 weeks ago
Rocklin, California, United States Randstad Life Sciences Full timeJob OverviewContract Type: 1 YearLocation: Rocklin, CAPay Rate: $20-25/hr Position Objective:The Laboratory Production Specialist in Manufacturing Histology will execute laboratory functions within the production facility, which includes slide production and packaging tasks, while assisting in processes necessary for block qualification. This role adheres to...
-
Construction Specialist I, II, or III
2 weeks ago
Rocklin, California, United States Astound Broadband Powered by Wave Full timeAbout the RoleAstound Broadband Powered by Wave is seeking a skilled Construction Specialist I, II, or III to join our team. As a key member of our construction team, you will be responsible for performing various installation and construction tasks to ensure the delivery of high-quality services to our customers.Key ResponsibilitiesInstallation and...
-
Customer Service Operations Manager
2 weeks ago
Rocklin, California, United States Solomon Page Full timeJob DescriptionWe are seeking a highly skilled Support Desk Quality Assurance Lead to join our team at Solomon Page. As a key member of our operations team, you will be responsible for ensuring high standards of service and efficiency within our support desk operations.Key Responsibilities:Voice of the Customer Analysis: Review and analyze feedback from...
-
Workers Compensation Claims Adjuster III
5 days ago
Rocklin, California, United States Intercare Holdings Insurance Services, Inc. Full timeJob SummaryIntercare Holdings Insurance Services, Inc. is seeking a highly skilled Workers Compensation Claims Adjuster III to join our team. As a key member of our claims department, you will be responsible for effectively managing to conclusion an assigned inventory of claim files that may include cases of extreme complexity or with unique or unusual...
-
Special Machine Construction Engineer
4 days ago
Rocklin, California, United States Stellar Enterprises Full timeWe are a successful, owner-managed group of companies in the manufacturing of equipment and machinery with approximately 350 employees worldwide. Shaped by tradition, sustainability, and a commitment to our employees, we are conquering global markets with high quality standards and a strong service culture. Tradition has connected us since 1842. To be a...