Compliance Quality Assurance Specialist Jobs

Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

Min. 3 years’ experience in healthcare with 1 year experience in health plan quality improvement, managed care, or equivalent experience.

Operational knowledge and experience with Excel and Visio (flow chart equivalent).

Creates, manages, and/or compiles the required documentation to maintain critical quality improvement functions.

Surfaces to Manager and Director any gaps in processes that may require remediation.

Demonstrated solid business writing experience.

Execute supplier complaint process with routine reports to management, assess supplier’s qualification status and communicate potential risks.

Serve as subject matter expert for supplier management during audits and regulatory inspections.

Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 10+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.

Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products

Manage the day-to-day activities and operations of the Corporate Audit and Supplier Quality Programs.

8+ years of quality systems experience in a Quality organization

2 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).

3 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).

2 years’ experience in a role requiring strong coordination skills; e.g., organization, communication, analysis (experience can run concurrently).

Knowledge of QA principles and theories.

Ability to apply leadership skills, assume responsibility and function under minimum supervision.

Work may require walking across campus or commuting to medical school site to conduct audits or provide education.

In conjunction with the Engineering, Validation and IT teams, develop and manage all qualification and validation policies, procedures, and protocols.

Basic math skills are required. Ability to apply concepts of basic algebra and statistics.

Sitting for long periods of time at a computer. Push and pull up to 30 lbs.

Salary Range: $165,000 - $195,000

Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.

Extensive experience in laboratory controls including analytical method validation, routine and stability testing, investigations, and change controls.

Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax

Capable to manage multiple priorities, adapt and maintain adherence to timelines

Demonstrated ability to manage process improvement projects

Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations

Strong project management and organization skills

Manage and coordinate Pharmacovigilance department SOP revision process

Excellent overall communication skills with demonstrated written and verbal communication skills

Assist with Pharmacovigilance audit and inspection activities

Collate KPI information for routine reviews

Collaborate with Pharmacovigilance team members to complete QMS elements such as deviations, change controls and CAPAs

The Specialist, QA Systems and Compliance will report to the Sr. Manager, Quality Systems and Compliance

Executes supplier audits and implements Astellas requirements where applicable.

Perform other support responsibilities as requested to support Quality and Regulatory oversight activities.

Proven ability to manage multiple projects while maintaining quality

Strong interpersonal skills with reputation for collaboration with colleagues

Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

Excellent writing skills and the ability to succinctly convey information to senior business and compliance management.

Keeping management apprised and recognizing when to escalate issues as needed.

At least 3 – 5 years of BSA/AML banking compliance or regulatory experience.

Experience working with FFIEC Exam Manual high risk customer types, including conducting CIP, KYC, and CDD / EDD.

Experience with transaction monitoring and case investigations, including Suspicious Activity Report filing.

CAMS and/or ACFCS certification desired.

Execute supplier complaint process with routine reports to management, assesses supplier’s qualification status and communicates potential risks.

Serve as lead corporate and supplier auditor and Supplier Quality Programs minimal guidance from management.

Serve as subject matter expert for supplier management during audits and regulatory inspections.

Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.

Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products

6+ years of quality systems experience in a Quality organization

Manage compliance: Ensure products adhere to all relevant safety, health, and environmental requirements imposed by local, national, and international governing bodies.

Improve supplier quality: Drive improvements in suppliers’ quality management systems.

BA/BS degree in a related field such as Engineering, Quality Assurance, Regulatory Affairs, or Risk Management

Provide leadership: Offer high quality and effective leadership to team members and present development opportunities to staff.

Experience within a product testing lab/facility is highly desired.

Excellent communication skills, with the ability to articulate complex compliance issues and potential risks to cross-functional partners and stakeholders.

Knowledge of supplier qualification processes and supplier performance metrics preferred

Minimum 5 years of relevant experience (preferably in retail)

Supplier Quality background and experience preferred

Knowledge of integrated ERP systems and world-class supply chain practices preferred

Possess good process experience, judgment and the ability to recognize key problems

Excellent communication skills (verbal and written)

Supports the follow-up of Corrective and Preventive Actions (CAPAs) arising from issue management reports and audits.

Bachelor’s Degree – preferably in a life science, or a combination of education and work experience relevant to the role.

Provides support for Inspection Readiness Activities, vendor qualifications, self-inspection projects and audits.

Prior experience supporting TMF Operations or Clinical Operations in support of TMF activities.

Experience preparing for and/or participating in regulatory inspections.

GCP-related certifications (e.g., SoCRA, SQA-RQAP, etc.).

Demonstrated successful experience as a Quality Assurance Director or equivalent in a nonprofit, government, or other clinical setting

Demonstrated planning and organizational skills

Superb written and oral communication skills

Hybrid work model - 3 days from home

Conduct and ensure compliance with all contractual, regulatory, and ethical obligations of the agency

Lead preparation and execution of all external and internal program audit activities (CARF, County, Medi-cal etc)

Actual compensation may vary from posting based on geographic location, work experience, education, and/or skill level.

Monitor and ensure timely and accurate completion of key quality activities, presenting results to management and other departments

Bachelor's Degree or equivalent combination of education and work experience

Minimum 3 years' experience in healthcare with 1 year experience in health plan quality improvement or managed care

Operational knowledge and experience with Excel and Visio

Competitive benefits and compensation package

Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.

Works with the management team to implement and execute the Inspection Readiness program; including Corporate Inspections and Global Health Authority Inspections.

Contributes significantly to the site inspection preparation, program management, response and commitment process.

Adheres to all GMP requirements.

Supports the development and oversight of robust quality systems, including both implementation and operation at site level.

Facilitates training on all QA Compliance programs.

Assist with updating reports, data entry and required documentation.

1+ years of experience in general office administration.

A comprehensive and highly competitive benefits package

Work from home and still be part of a team!

Professionally handle and direct all phone interactions in a timely and courteous manner.

Respond to emails, chats, and texts in a timely manner in accordance with department SLAs within the CST Organization.

Experience with risk management facilitation is required.

Assist/conduct training for risk management, investigations, change controls, auditing, supplier management programs, and other processes as needed.

Formal Risk Management training is recommended.

Conduct audits of suppliers to ensure they comply with their procedures, regulations, and Polaris Pharmaceuticals, Inc. requirements.

Develop familiarity and keep current with cGMP and applicable regulatory requirements as needed.

Excellent written, verbal, and communication skills.

1–2 years’ experience in the principles and practices of compliance, quality management, and quality assurance, preferably in the wine industry.

Strong self-management skills, with the added ability to take initiative, multi-task, be innovative and work under pressure.

Perform daily and weekly wine lot data entry tracking and traceability; ensure software transactions are performed accurately and timely.

Perform data entry audits by wine tiers to ensure accuracy and completeness. 

Be well-versed and knowledgeable in federal and state regulations for wine and spirits.

Certification for quality control (such as ISO 9000) is a plus.

Support Quality Management Review, Annual Product Review, Deviation Review Board, Change Review Board and CAPA review board initiatives.

BA/BS degree (preferred) with at least 2 years of Quality Assurance working experience in pharmaceutical industry providing Quality Assurance oversight.

Demonstrated data analysis and analytical tool experience.

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP systems.

Risk Management: Participate in the Risk Management program, including updating risk analysis, participating in applicable teams and maintaining Risk Management documents.

Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).

Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.

Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance.

Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.