Quality and Compliance Specialist II/III

2 weeks ago

Vacaville, United States Polaris Pharmaceuticals Inc. Full time

Role Summary


The Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be responsible for conducting internal audits, participating in third-party audits, participating in and/or leading efforts towards site-preparedness/readiness for regulatory inspections. Additionally in this role, they will create schedules, select/manage audit team members, and manage work of self and team members.


PRIMARY ROLE RESPONSIBILITIES


  • Establish and maintain quality agreements with suppliers and contract test laboratories.
  • Maintain supplier qualification through audits and questionnaires, including managing, scheduling, conducting audits of suppliers and contract test laboratories.
  • Lead and conduct internal quality audits in manufacturing, QC, facilities, warehouse, and utility areas according to established procedures, cGMP and company standards.
  • Evaluate audit findings and ensure the implementation of appropriate corrective actions.
  • Train auditors according to established procedures, cGMP and company standards.
  • Review batch records, in-process documents, analytical data, and other documentation to ensure compliance with corresponding procedures, cGMP and company standards.
  • Assist as needed in generation, review, and approval of protocols, reports, and other documents for regulatory submissions.
  • Participate in and/or host third-party audits.
  • Participate in and/or lead efforts towards site-preparedness/readiness for regulatory inspections (including PAI/PLI).
  • Prepare/present reports to stakeholders (e.g. Executives, Quality Review Board, Management, etc.).


SKILLS


  • Sound knowledge of cGMPs
  • Excellent written and verbal communication skills, including the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management / executives.
  • Strong interpersonal and leadership skills, along with adaptability, integrity, self-awareness, collaboration, and advocating for continuous improvement.
  • Must be able to prioritize a variety of competing tasks.


QUALIFICATIONS


Education/Experience:

  • B.S./B.A. in science-related field plus 6-8 years of related work experience in an FDA- regulated GMP environment, or
  • M.S. in science-related field plus 3-6 years of related work experience in an FDA-regulated GMP environment.
  • Experience with cGMP environments and quality systems is required.
  • CQA or other auditor qualification / certification is preferred.
  • Experience with hosting audits and interacting with health authority agencies is a plus.

  • Quality and Compliance Specialist II/III

    1 month ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role SummaryThe Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be...

  • Compliance Specialist

    4 weeks ago

    Vacaville, United States Sterling Asset Management Company Full time

    **COMPLIANCE MANAGER** **Summary**: The Compliance Specialist reports to the Director of Property Management and is responsible for remaining current on affordable housing financing program regulations with specific focus on resident income eligibility determinations; training property management staff on program compliance procedures; approving eligibility...

  • Building Inspector III

    3 weeks ago

    Vacaville, California, United States 4LEAF Full time

    : 4LEAF, Inc. (4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. 4LEAF is seeking highly qualified full-time senior commercial building inspectors in the Solano County Area....

  • Building Inspector III

    14 hours ago

    Vacaville, United States 4LEAF, Inc Full time

    Job DescriptionJob DescriptionDescription:4LEAF, Inc. (4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. 4LEAF is seeking highly qualified full-time senior commercial building...

  • Building Inspector III

    1 week ago

    Vacaville, United States 4LEAF, Inc Full time

    Description: 4LEAF, Inc. (4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. 4LEAF is seeking highly qualified full-time senior commercial building inspectors in the Solano...

  • Inventory Control Specialist II

    1 week ago

    Vacaville, United States Select Staffing Full time

    Description Inventory Control Specialist II Location: Vacaville, CA Schedule: Monday - Friday 8:00 AM - 4:30 PM, must be available to work overtime Pay Rate: $27.00 an hour JOB SUMMARY This employee is responsible for monitoring and processing Blue Mountain inventory to ensure proper record-keeping and inventory accuracy. ESSENTIAL DUTIES AND...

  • Business Analyst III

    1 week ago

    Vacaville, United States Russell Tobin & Associates Full time

    What are we looking for in our Business Analyst III? The Information Technology team at Russell Tobin & Associates is supporting a top financial organization that has an opening for a Business Analyst III role. Below is some information about an immediate opportunity for which you might be interested: Location: Hybrid to Vacaville, CA Pay...

  • Medical Social Worker II

    4 weeks ago

    Vacaville, United States Kaiser Permanente Full time

    Job Summary: The primary role of the Medical Social Worker II is to assist patients and families/caregivers to cope with the social/emotional issues and practical arrangements related to the patients illness. Under general direction of the Social Work Manager/LCSW, delivers age-appropriate social work care to patients and their caregivers in accordance with...

  • Medical Social Worker Ii

    4 weeks ago

    Vacaville, United States Kaiser Permanente Full time

    **Job Summary**: The primary role of the Medical Social Worker II is to assist patients and families/caregivers to cope with the social/emotional issues and practical arrangements related to the patients illness. Under general direction of the Social Work Manager/LCSW, delivers age-appropriate social work care to patients and their caregivers in accordance...

  • Quality Assurance Specialist I, QA Operations

    3 weeks ago

    Vacaville, California, United States Polaris Group Full time

    ROLE SUMMARY The QA Specialist is responsible for ensuring that quality requirements are established and maintained in accordance with the appropriate regulations and cGMP guidelines. This role is to act as a quality liaison to other departments within the company. The specialist is a model to junior associates through exhibition of high productivity,...

  • Quality Assurance Specialist I, QA Operations

    1 month ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    ROLE SUMMARY The QA Specialist is responsible for ensuring that quality requirements are established and maintained in accordance with the appropriate regulations and cGMP guidelines. This role is to act as a quality liaison to other departments within the company. The specialist is a model to junior associates through exhibition of high productivity,...

  • Quality Assurance Specialist I, QA Operations

    1 month ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    ROLE SUMMARY The QA Specialist is responsible for ensuring that quality requirements are established and maintained in accordance with the appropriate regulations and cGMP guidelines. This role is to act as a quality liaison to other departments within the company. The specialist is a model to junior associates through exhibition of high productivity,...

  • Medical Social Worker II

    7 days ago

    Vacaville, United States Kaiser Permanente Full time

    Job Summary: The primary role of the Medical Social Worker II is to assist patients and families/caregivers to cope with the social/emotional issues and practical arrangements related to the patients illness. Under general direction of the Social Work Manager/LCSW, delivers age-appropriate social work care to patients and their caregivers in accordance with...

  • property controller ii

    6 days ago

    Vacaville, California, United States California Department of Corrections and Rehabilitation Full time

    Job Posting: Property Controller II, CF California Medical Facility JC-439644 - Property Controller II, CFPROPERTY CONTROLLER II (CORRECTIONAL FACILITY) $4, $5,849.00 per Month Final Filing Date: 7/18/2024 Job Description and Duties Under the supervision of the Business Services Officer I (Supervisor), the Property Controller II, CF, is responsible...

  • Material Handler I

    1 month ago

    Vacaville, United States Thistle Health Inc. Full time

    **Material Handler I & II** Vacaville, CA / Operations - Warehouse / Full-time Who we are Founded in 2013, Thistle is an early-stage food-tech startup empowering our customers to get and stay healthy while improving the sustainability of our food system. We deliver delicious, organic, healthy, plant-forward meals, cold-pressed juices, and snacks to...

  • Business Analyst III

    2 days ago

    Vacaville, United States Russell Tobin Full time

    Job DescriptionJob DescriptionThe Information Technology team at Russell Tobin & Associates is supporting a top financial organization that has an opening for a Business Analyst III role.Below is some information about an immediate opportunity for which you might be interested:Location: Hybrid to Vacaville, CAPay Range: $73/HR - $78/HR on W2Type: 8 months...

  • Business Analyst III

    6 days ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC is actively looking for a Business Analyst III in the Vacaville, CA area!BA/BS degree in computer science, supply chain, business, or engineering fields. 8-months contract with possible extensions!Benefits include medical, dental, vision, and life insurancePay Rate: $76.49-$80.49/hourThis position is hybrid with a mandatory 3 days onsite.***NO C2C...

  • Medical Social Worker II

    1 week ago

    Vacaville, United States Kaiser Permanente Full time

    Description: Job Summary:The primary role of the Medical Social Worker II is to assist patients and families/caregivers to cope with the social/emotional issues and practical arrangements related to the patients illness. Under general direction of the Social Work Manager/LCSW, delivers age-appropriate social work care to patients and their caregivers in...

  • Speech Therapist II

    1 week ago

    Vacaville, United States Kaiser Permanente Full time

    Description: Job Summary:Provides diagnosis and treatment of communication disorders for more complex cases. Ensures compliance with standards and regulatory requirements. Oversees work of entry-level staff and supports community programs.UNAC/UHCP (United Nurses Association of California/Union of Health Care Professionals) is the collective bargaining...

  • Laboratory Assistant II

    3 weeks ago

    Vacaville, California, United States Kaiser Permanente Full time

    Under the direction and oversight of the Laboratory Director and Laboratory Manager, or designee, within the scope of Unlicensed Laboratory Personnel as described in B&PC 1269, receives and processes specimens, performs clerical tasks and performs phlebotomy. May operate automated or semi-automated test equipment, or plate and process microbiology specimens...