Top 12 Quality assurance associate Jobs in Weston, Fl

Associate Director, Quality Assurance and Compliance
Transpire BIO Inc. —Weston, FL
- Full-time
- 5 years
- Bachelor of Science
- English
Quick Apply
1d
Associate Director, Quality Assurance and Compliance
Transpire Bio —Weston, FL
- Full-time
- 5 years
- Bachelor of Science
- English
1d
Quality Control & Shipping Associate (2nd Shift)
LightFire Group —Tamarac, FL
- Overtime
- Ability to walk for extended periods
- Ability to lift 50 pounds
- Warehouse
- Dental insurance
- Paid time off
Quick Apply
Quality Assurance Associate
CEDENT —Pompano Beach, FL
- Organizational skills
- Associate's degree
- Communication skills
Quality Assurance Associate
Lupin Pharmaceuticals Inc. —Coral Springs, FL
- Full-time
- Bachelor of Science
- English
- Mid-level
Quality Assurance Associate
Freshpoint —Pompano Beach, FL
- Monday to Friday
- Management
- Writing skills
- Mid-level
Health Insurance Compliance and Quality Assurance Associate
GetMeHealthcare —Deerfield Beach, FL
- $18 an hour
- Full-time
- Customer service
- Computer literacy
- Office
- Health insurance
- Dental insurance
Quick Apply
Sample Associate, Warehouse
FOH, INC. —North Miami, FL
- $16 an hour
- Full-time
- Customer service
- Computer literacy
- High school diploma or GED
- Paid holidays
- Health insurance
Quick Apply

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Associate Director, Quality Assurance and Compliance

Transpire BIO Inc.
Weston, FL

Quick Apply

Job Details

Full-time
1 day ago

Qualifications

FDA submissions
EHS
Analytical chemistry
Team leadership
Drug regulation
Technical writing experience within manufacturing
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Compliance documentation
Regulatory/legal compliance standards in production
Regulatory submission editing and review
GMP for research safety and compliance

Full Job Description

Position Summary:

Provides QA and compliance leadership and work with internal teams, and external auditors, to ensure compliance across all R&D and manufacturing projects of the company. The job holder will be responsible for the execution and administration/maintenance of Transpire Bio Quality Management System that is consistent with current Good Laboratory Practices (cGLP) and/or Good Manufacturing Practices (cGMP) as well as applicable regulatory requirements. Additionally, the position will have overall responsibility for monitoring, controlling, training, and management to ensure the site maintains a best-in-class system for product quality assurance.

Essential Duties and Functions:

Implement and/or revise corporate standard documents relating to GxP such as quality manuals, policies, SOPs, work instructions, forms, reference documents, in collaboration with relevant business functions.

Execute, and maintain the document control system to ensure appropriate level of Quality oversight to GxP documentation.

Review and update quality manuals, SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGxP standards, FDA/EMA/MHRA/ICH and other applicable competent authority regulations and requirements.

Assist and participate in the coordination and responses to audits and inspections.

Maintain the employee training program including assessments of its’ effectiveness, in collaboration with business functions.

Ensure compliance of manufacture and testing of product for clinical studies; lead in resolution of quality non-compliance issues in production and testing at labs or at vendors; identify areas of improvement.

Establish and maintain appropriate development phase compliance requirements for product manufacture, testing, and stability; review and assess production and testing methods, specifications, validations, reference materials and test results.

Review applicable documentation from internal and external sources as well as applicable sections of regulatory submissions for compliance with documentation, established standards, and regulations.

Provide hands-on leadership, oversight, and execution of the Quality Assurance team by providing learning and development where appropriate.

Ensure the on-time initiation and closure of documents related to deviations & investigations, CAPAs, change controls, SOPs with thorough & standardized supporting documentation.

Support both corporate and site management through the identification and introduction of facility upgrades and innovative solutions that drive continuous improvement.

Qualifications Required:

BS degree in analytical chemistry, pharmaceutical sciences or related discipline with at least 5 years of experience of managing pharmaceutical QA department.

Extensive knowledge and full understanding of ICH guidelines, Pharmacopeia requirements, US and European regulatory guidelines on Chemistry, Manufacture and Control of drug products.

Extensive knowledge and full understanding of GLP, cGMP, COSHH, EH&S, relevant legal and ethical codes for pharmaceutical development and manufacture.

Experience in working in compliance with US, EU, and ICH GMP requirements, experience with writing or reviewing submission documentation, responses to regulatory inquiries and inspections.

Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, ISO and ICH Regulations and guidelines.

Preferred hand-on experience with product development for inhalation dosage forms, understanding the GMP requirements of different phases of product development. Technical knowledge of analytical method qualification, process validation, establishing product specifications, and facility qualification

Skills:

Ability to make Quality decisions related to manufacturing, investigations, documentation, CAPA, change control, and regulatory compliance.

Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.

Strong interpersonal communication and leadership skills, ability to influence decisions up to strategic levels and effectively communicate with employees at all levels.

Strong English language skills including writing ability and oral communication.

Why Join Us?

We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.

Quick Apply

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quality assurance associate jobs in weston, fl

Associate Director, Quality Assurance and Compliance

Associate Director, Quality Assurance and Compliance

Quality Control & Shipping Associate (2nd Shift)

Quality Assurance Associate

Quality Assurance Associate

Quality Assurance Associate

Health Insurance Compliance and Quality Assurance Associate

Sample Associate, Warehouse

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