Remote Pharmaceutical Quality Assurance Specialist

Placements24; United States; Remote; USD 95.000 - 125.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental & Vision

Paid time off

Retirement plan

Online training

Zusammenfassung

Placements24 client is seeking a remote Pharmaceutical Quality Assurance Specialist to support dispersed operations in the United States. The role ensures products meet quality standards and regulatory requirements across manufacturing, testing, and distribution.

The ideal candidate will have a solid background in cGMP, ICH guidelines, and auditing, with the ability to work independently from a remote setting while maintaining rigorous documentation.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biology or related field.
• 5+ years in Pharmaceutical QA/QC.
• In-depth knowledge of cGMP, ICH guidelines, and regulations.
• Experience with auditing, deviation management and CAPA systems.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication for remote collaboration.

Aufgaben

• Develop, implement, and maintain QA systems and SOPs.
• Conduct internal and supplier audits for compliance.
• Review and approve batch records and validation protocols.
• Investigate deviations and CAPAs.

Kenntnisse

QA Systems

SOP Development

Auditing

CAPA

cGMP Knowledge

Ausbildung

Bachelor's in Pharmacy/Related

Jobbeschreibung

About the Role

Our client is seeking a detail-oriented and highly motivated Remote Pharmaceutical Quality Assurance Specialist to join their dispersed team, supporting operations in George . This critical role ensures that all pharmaceutical products meet stringent quality standards and regulatory requirements. You will be instrumental in maintaining compliance across manufacturing, testing, and distribution processes. The ideal candidate will possess a thorough understanding of pharmaceutical quality systems and a proactive approach to identifying and mitigating risks, working independently to uphold the highest levels of product integrity from a remote setting.

Key Responsibilities

• Develop, implement, and maintain Quality Assurance (QA) systems and Standard Operating Procedures (SOPs).


• Conduct internal audits and supplier audits to ensure compliance with cGMP and other relevant regulations.


• Review and approve batch records, validation protocols, and other quality-related documentation.


• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).


• Participate in regulatory inspections and support continuous improvement initiatives across the organization.


• Provide training to personnel on quality systems and cGMP principles as needed.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.


• Minimum of 5 years of experience in Pharmaceutical Quality Assurance or Quality Control.


• In-depth knowledge of current Good Manufacturing Practices (cGMP) , ICH guidelines, and other relevant pharmaceutical regulations.


• Experience with auditing, deviation management, and CAPA systems.


• Excellent analytical, problem-solving, and organizational skills.


• Strong written and verbal communication skills, with the ability to effectively collaborate remotely.

Benefits

• Competitive annual salary with remote work flexibility.


• Comprehensive health, dental, and vision insurance.


• Generous paid time off and sick leave.


• Retirement savings plan with company contribution.


• Access to online professional development resources and training programs.