QA Documentation & Compliance Specialist

Acrotech Biopharma inc.; East Windsor Township (NJ); On-site; USD 72,000 - 81,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive plan

Medical benefits—4 plans

Dental benefits

Vision plan

Life insurance

Disability insurance

401(k) with match

Paid time off

Job summary

Acrotech Biopharma Inc. is seeking a QA Specialist to support Quality Assurance functions, reporting to the Sr. Director of QA. You will organize GXP documentation, assist with training and budget activities, and help manage contractor oversight for production and testing.

The role emphasizes document accuracy, clear communication, and ensuring procedures align with Acrotech SOPs. Domestic and international travel may occur, <5%.

Qualifications

• Attention to detail and strong organizational skills are essential.
• Excellent written and verbal communication abilities are required.
• Proficiency with MS Word, Excel, PowerPoint, Outlook; familiarity with SharePoint, Visio, Oracle is a plus.

Responsibilities

• Organize documentation and ensure ease of identification and retrieval.
• Assist in issuing purchase orders, invoices, and budget development.
• Assist in organizing, maintaining, writing and reviewing GxP documents for products and contractor oversight.
• Prepare and review certificates of analysis, certificates of conformance, batch records, specifications, investigations and change controls.
• Review deviations, CAPA, complaint investigations and change controls for completeness and SOP adherence.
• Draft and review SOPs and assist with annual product reviews and trend stability data.

Skills

Attention to detail

Organizational skills

Critical thinking

Excellent communication

MS Word

MS Excel

PowerPoint

Outlook

SharePoint

Visio

Oracle

Education

Bachelor’s degree in chemistry, life sciences, or related field

GMP experience (3 years)

Tools

MS Word

MS Excel

PowerPoint

Outlook

SharePoint

Visio

Oracle

Job description

Acrotech Biopharma Inc. is seeking a QA Specialist to support Quality Assurance functions, reporting to the Sr. Director of QA. You will organize GXP documentation, assist with training and budget activities, and help manage contractor oversight for production and testing.

The role emphasizes document accuracy, clear communication, and ensuring procedures align with Acrotech SOPs. Domestic and international travel may occur, <5%.