Remote Biotech QA Specialist: GMP & Regulatory

Actalent; United States; Remote; USD 48,000 - 69,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) plan

Life Insurance

Disability insurance

HSA

Job summary

Actalent is seeking a QA Specialist to join our Quality & Compliance team in the biotechnology sector. You will support QA processes, ensure FDA/EMA compliance, and collaborate with cross-functional teams to uphold product quality and safety.

The role involves batch record review, deviation investigations, QMS improvements, and preparation for audits. Remote work is available with first-shift hours, based in Philadelphia area.

Qualifications

• Bachelor's Degree in Life Sciences or related field.
• Minimum of 3 years in biopharmaceutical operations or quality.

Responsibilities

• Perform batch record review and release for US and ex-US trials.
• Investigate quality issues including deviations and OOS results.
• Collaborate with CDMOs and internal CMC teams to ensure quality.
• Provide QA support to CMC throughout product lifecycle.
• Review and approve transfer documents and test methods.
• Maintain and improve the QMS in line with regulatory requirements.
• Assist in creating SOPs and related documents.
• Compile metrics and manage document control processes.
• Assist in audits and address findings with corrective actions.
• Assist in regulatory filings and submissions.

Job description

Actalent is seeking a QA Specialist to join our Quality & Compliance team in the biotechnology sector. You will support QA processes, ensure FDA/EMA compliance, and collaborate with cross-functional teams to uphold product quality and safety.

The role involves batch record review, deviation investigations, QMS improvements, and preparation for audits. Remote work is available with first-shift hours, based in Philadelphia area.