Biotech QA Specialist – Remote Quality Assurance

Actalent; United States; À distance; USD 48 000 - 69 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Savings Account

Transportation benefits

Employee Assistance Program

PTO / Vacation

Résumé du poste

Actalent is seeking a QA Specialist to join our Quality & Compliance team in the biopharma sector. You will support QA processes, ensure regulatory compliance (FDA/ EMA), review batch records, investigate quality issues, and collaborate with CDMOs and internal CMC teams to safeguard product integrity throughout development and manufacture.

The role emphasizes maintaining a robust QMS, document control, audits, and preparation for regulatory filings.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 3 years biopharma operations, quality or QC/QA roles.
• Experience with audits, deviations, change control, CAPAs.
• Strong knowledge of GMP, GCP, ICH and US/EU/UK regulations.
• Strong interpersonal and leadership skills; able to build professional relationships.

Responsabilités

• Perform batch record review and release for US and ex-US trials.
• Investigate and address product quality issues, deviations and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure quality from development to commercialization.
• Provide quality support to CMC throughout product lifecycle.
• Review and approve technical transfer docs: protocols, reports, master batch records, test methods.
• Maintain and improve the Quality Management System (QMS) per policies and regulatory standards.
• Assist in creating and maintaining SOPs, policies, and related documents.
• Compile metrics for internal and external operations and manage document control processes.
• Prepare for and support internal/external audits and address audit findings.
• Assist in regulatory filings and submissions.

Connaissances

GMP knowledge

GCP/ICH regulations

Quality Assurance

Documentation control

Auditing

Communication skills

Formation

Bachelor's Degree in Life Sciences

Outils

QMS software

Description du poste

Actalent is seeking a QA Specialist to join our Quality & Compliance team in the biopharma sector. You will support QA processes, ensure regulatory compliance (FDA/ EMA), review batch records, investigate quality issues, and collaborate with CDMOs and internal CMC teams to safeguard product integrity throughout development and manufacture.

The role emphasizes maintaining a robust QMS, document control, audits, and preparation for regulatory filings.