Current jobs related to QA-Regulatory & Document Coordinator for makers of BioAstin - Honolulu, Hawaii - Cyanotech - Makers of BioAstin

  • Regulatory Compliance Director

    3 weeks ago

    Honolulu, Hawaii, United States HealthEdge Software Inc Full time

    Job SummaryWe are seeking a highly experienced Regulatory Compliance Director to join our team at HealthEdge Software Inc. As a key member of our organization, you will be responsible for ensuring that our clinical suite of products supports our health plan customers in achieving and maintaining compliance with regulatory bodies.Key...

  • Commercial Loan Documentation Specialist

    2 weeks ago

    Honolulu, Hawaii, United States First Hawaiian Bank Full time

    About the RoleFirst Hawaiian Bank is seeking a skilled Commercial Loan Documentation Specialist to join our team in the Commercial Loan Center. In this role, you will be responsible for preparing loan documentation and coordinating loan closing for commercial loans in accordance with company policies and procedures and applicable governmental laws and...

  • Loan Documentation Specialist

    7 days ago

    Honolulu, Hawaii, United States Central Pacific Bank Full time

    Job SummaryWe are seeking a highly skilled Loan Documentation Specialist to join our team at Central Pacific Bank. As a key member of our loan documentation team, you will be responsible for preparing and reviewing complex commercial loan documents, ensuring accuracy and compliance with regulatory requirements.Key ResponsibilitiesPrepare and review...

  • Compliance Director

    4 weeks ago

    Honolulu, Hawaii, United States AlohaCare Full time

    About the RoleAlohaCare is seeking a highly skilled Compliance Director to promote a culture of compliance, ethics, and integrity within our organization.Key ResponsibilitiesCompliance Program Management: Direct and manage Compliance programs, policies, and practices to ensure all business units are in compliance with Medicaid and Medicare policy and...

  • Lead Regulatory Affairs Specialist

    3 weeks ago

    Honolulu, Hawaii, United States Oracle Full time

    Job SummaryWe are seeking an experienced Regulatory Compliance Specialist to join our team at Oracle.Key Responsibilities:Assist in ensuring compliance with government regulations and/or regulatory agencies.Support the organization in complying with regulatory requirements.Develop regulatory strategies and roadmaps for Medical Device programs.Train...

  • Care Coordinator Specialist

    3 weeks ago

    Honolulu, Hawaii, United States Centene Corporation Full time

    Job SummaryCentene Corporation is seeking a highly skilled Care Coordinator II to join our team. As a Care Coordinator II, you will play a critical role in supporting care management activities and ensuring services are delivered to our members.Key ResponsibilitiesSupports care management activities and teams assigned to members to ensure services are...

  • Document Control Specialist

    6 days ago

    Honolulu, Hawaii, United States HomeSafe Alliance Full time

    Job Title: Document Control CoordinatorAbout the Role:HomeSafe Alliance is seeking a highly skilled and motivated Document Control Coordinator to ensure that organizational documents are prepared, maintained, distributed, updated, and stored according to HomeSafe's document management standards.Key Responsibilities:Implement existing document control...

  • Care Coordinator Specialist

    2 weeks ago

    Honolulu, Hawaii, United States Centene Corporation Full time

    {"title": "Care Coordinator II", "description": "Job SummaryAt Centene Corporation, we're transforming the health of our communities, one person at a time. As a Care Coordinator II, you'll play a vital role in supporting our members and ensuring they receive the best possible care.Key ResponsibilitiesSupport care management activities and teams to deliver...

  • Commercial Loan Documentation Specialist

    6 days ago

    Honolulu, Hawaii, United States First Hawaiian Bank Full time

    Commercial Loan Documentation SpecialistAt First Hawaiian Bank, we're committed to fostering a culture of excellence and teamwork. As a Commercial Loan Documentation Specialist, you'll play a vital role in preparing loan documentation and coordinating loan closings for commercial loans. Your attention to detail and excellent communication skills will ensure...

  • Compliance Management Lead

    3 weeks ago

    Honolulu, Hawaii, United States J&J Family of Companies Full time

    Job SummaryWe are seeking a highly skilled Compliance Management Lead to join our team at J&J Family of Companies. As a key member of our organization, you will be responsible for overseeing and managing our compliance monitoring process, ensuring adherence to relevant laws, regulations, industry standards, and company policies/procedures.Key...

  • Construction Project Coordinator

    4 weeks ago

    Honolulu, Hawaii, United States Hawaiian Dredging Construction Company, Inc. Full time

    Construction Project Coordinator Job OverviewThe Construction Project Coordinator plays a crucial role in managing the construction initiative from inception to completion, ensuring that it aligns with the expectations of the stakeholders. This position involves providing direction to project supervisors and technical teams, with an emphasis on timelines,...

  • Program Coordinator

    6 days ago

    Honolulu, Hawaii, United States Alakaina Foundation Family of Companies Full time

    Job SummaryThis position requires a highly skilled executive assistant who can support in a program coordinator/event coordinator type role. The ideal candidate will have experience in gathering and pushing out information, as well as knowledge of the general military ranking and communications infrastructure.Key ResponsibilitiesWork with the commander and...

  • Program Coordinator

    4 weeks ago

    Honolulu, Hawaii, United States Alakaina Foundation Family of Companies Full time

    This role demands a highly skilled executive assistant capable of functioning in an event coordinator or program coordinator capacity. Candidates should excel in information gathering and dissemination (knowledge management), with less emphasis on technical comprehension, as this responsibility will be managed by Government civilian personnel. While an...

  • Program Coordinator

    4 weeks ago

    Honolulu, Hawaii, United States Alakaina Foundation Family of Companies Full time

    This role necessitates a highly skilled executive assistant capable of functioning in an event coordinator or program coordinator capacity. Candidates should excel in information gathering and dissemination (knowledge management), with less emphasis on technical comprehension, as that responsibility will be managed by Government civilian personnel. While an...

  • Inbound Logistics Coordinator

    2 weeks ago

    Honolulu, Hawaii, United States Sysco Full time

    Company Overview:Sysco is a leading foodservice distribution company with a global presence, operating over 333 distribution facilities worldwide and serving more than 700,000 customer locations.Job Summary:We are seeking a highly skilled Inbound Logistics Coordinator to join our team. As a key member of our distribution center, you will be responsible for...

  • Program Coordinator

    2 weeks ago

    Honolulu, Hawaii, United States Alakaina Foundation Family of Companies Full time

    Job SummaryThis position requires a highly skilled executive assistant who can support in a program coordinator/program manager type role. The ideal candidate should be proficient in gathering and disseminating information, with a strong understanding of knowledge management principles. Experience in a high-demand, high-visibility executive assistant...

  • Communication Coordinator

    4 weeks ago

    Honolulu, Hawaii, United States Bishop & Company Full time

    Bishop & Company is in search of a Communication Coordinator to join a medical management team within a local insurance firm. This role will facilitate verbal interactions and the production/distribution of written notifications necessary for adherence to governmental and regulatory standards. The candidate must possess the ability to adhere to tight...

  • Senior Project Architect/Project Manager

    2 weeks ago

    Honolulu, Hawaii, United States Fashion Institute of Design & Merchandising Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Project Architect/Project Manager to join our team at the Fashion Institute of Design & Merchandising. As a key member of our architectural team, you will be responsible for leading multidisciplinary teams and overseeing the layout and detailing of architectural projects.Key...

  • Program Referral Coordinator

    1 day ago

    Honolulu, Hawaii, United States The Institute for Human Services, Inc. Full time

    Job Title: Program Referral SpecialistJob Summary:The Institute for Human Services, Inc. is seeking a highly skilled Program Referral Specialist to join our team. As a key member of our operations team, you will play a critical role in ensuring the successful placement of hospital referrals to our specialty shelters.Key Responsibilities:Provide...

  • Legal Support Coordinator

    4 weeks ago

    Honolulu, Hawaii, United States Express Employment Professionals of Hawaii Full time

    Job OverviewPosition: Legal Support CoordinatorLocation: Honolulu, HICompensation: $29.25/hrWork Hours: 8am-5pm, weekdays, flexibleBenefits Offered:Weekly paychecksReferral BonusesMedical & Dental CoverageHoliday CompensationParking Available· Additional perks & benefits Position Summary:A reputable legal firm is seeking a meticulous and organized...

QA-Regulatory & Document Coordinator for makers of BioAstin

3 months ago

Honolulu, Hawaii, United States Cyanotech - Makers of BioAstin Full time
Job Description

Job Description

Description Summary

This is a full-time, non-exempt position that is responsible for day-to-day quality assurance and regulatory functions including dietary supplement labeling and marketing material review, certification management, and international export support including product registrations.

This position is responsible for management of master manufacturing records, batch records, and other Good Manufacturing Practices (GMPs), Hazard Analysis of Critical Control Points (HACCP), Food Safety and Modernization Act (FSMA), and State Department of Health (DOH) records.

Essential Job Responsibilities
·

Coordinates efforts in maintaining all applicable registrations and certifications (such as Bioterrorism, Non-GMO Project verification,

Kosher, Gluten Free, DOH, and GMP).
·

Maintains bulk, Nutrex, and private label master files and ensures that interdepartmental communication of change occurs.
·

Assists with review of dietary supplement product labels, labeling, including marketing materials for regulatory compliance.
·

Supports new product development and international export efforts, through collection and organization of quality and regulatory files.
·

Maintains up-to-date component, ingredient, and product specifications, product tool kits, vendor specifications, testing agreements,

and GMP Agreements.
·

Manages the TMS Document Control System, implements upgrades, and provides trouble shooting and technical support.
·

Maintains and updates cGMP Master Manufacturing Records and Batch Records and ensures that all records are appropriately

retained and archived.
·

Supports product release with Batch Record review and COA generation.
·

Organizes and audits GMP records, including but not limited to Non-conforming Product Reports (NCPR),

Correction/Prevention

Action Reports (CPARS), Customer Complaints /Specifications, Management of Change (MOC), Vendor

Approval/Evaluation,

Equipment Verification, Batch Records, Sanitation and Production Logs, Label revisions, product specifications, Vendor Management,

Risk Assessment documentation.
·

Maintains bulk, Nutrex, and private label master files and ensures that interdepartmental communication of change occurs.
·

Conducts Master File Management for New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) compliance.
·

Conducts daily GMP/HACCP walk-throughs and sanitation sign off.
·

Provides sales support for customer inquiries and documentation requests.
·

Assists with external audit preparation and serves as a back-up audit scribe.
·

Manages documentation for contract manufacturers, co-packers, and vendors.
·

Ensures that Vendor Management files are current and evaluations occur as scheduled.
Other Duties
·

Serves as the secondary Scribe in FDA inspections.
·

Audits Quality Management System through periodic reviews of SOPs and controlled documents used in each Department.
·

Assists with interdepartmental document organization and retention.
·

Performs other duties that may be assigned.
Physical Demands

This position includes sitting at a computer for extended periods of time, as well as working in a laboratory standing at a bench.

May include occasional lifting of up to 40 pounds.

Working Conditions
Work is primarily performed in an office environment. Occasional work in document archive trailer.
Minimum Qualifications
·

Bachelor's degree or equivalent combination of work experience and education, preferred.
·

Previous work experience with GMP standards in relevant industry is preferred.
·

Proficiency with PC-based computer applications including Microsoft Word, Excel, and Outlook.
·

Excellent organizational, administrative and time management skills, as well as attention to detail.
·

Preferred Certified Quality Improvement Associate through ASQ or equivalent organization.
·

Able to work independently as well as part of a team.
·

Strong verbal, written and interpersonal skills.
·

Able to perform the essential functions of the position with or without reasonable accommodation.

Post-offer background check and drug screen are performed. Must be 18 years or older. All applicants must provide a resume. Cyanotech does not currently have a visa program.

Cyanotech Corporation is an EOE

Minorities/Women/Disability/Veterans
Company Description Cyanotech is the maker of BioAstin and Hawaiian Pacifica Spirulina. We have been in business for over 30 years.

As a world leader in the production of high value natural products derived from microalgae, we are guided by the principle of providing high quality microalgae products for health and human nutrition in a sustainable, reliable and environmentally sensitive operation.

We are third party certified to GMP (Good Manufacturing Practices) for dietary supplements, reinforcing our commitment to quality in our products, quality in our relationships (with our customers, suppliers, employees and the communities we live in), and quality of the environment in which we work.

Company Description

Cyanotech is the maker of BioAstin and Hawaiian Pacifica Spirulina. We have been in business for over 30 years.

As a world leader in the production of high value natural products derived from microalgae, we are guided by the principle of providing high quality microalgae products for health and human nutrition in a sustainable, reliable and environmentally sensitive operation.

We are third party certified to GMP (Good Manufacturing Practices) for dietary supplements, reinforcing our commitment to quality in our products, quality in our relationships (with our customers, suppliers, employees and the communities we live in), and quality of the environment in which we work.

#J-18808-Ljbffr