GMP Compliance Associate

Virtue America; Pennsylvania; On-site; USD 55,000 - 90,000; Full time

Job summary

Virtue America is seeking a detail-oriented GMP Compliance Associate to support GMP compliance activities in the pharmaceutical sector. You will review manufacturing records and SOPs, support audits, and ensure adherence to FDA regulations and internal quality standards.

The role suits candidates with Life Sciences backgrounds and a keen eye for quality documentation, CAPA tracking, and cross-functional collaboration with QA, QC, and Regulatory Affairs teams.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, or Life Sciences.
• Basic understanding of GMP and cGMP requirements.
• Familiarity with SOPs, batch records, quality documentation, and document control.
• Basic knowledge of deviation management, CAPA, and quality assurance processes.
• Strong attention to detail and organizational skills.
• Good written and verbal communication skills.
• Proficiency with Microsoft Office (Word and Excel).
• Fresh graduates or 0-2 years of experience encouraged to apply.

Responsibilities

• Support the implementation and maintenance of GMP procedures and quality standards.
• Review batch manufacturing records, SOPs, and other quality-related documents.
• Assist with document control activities, including document preparation, review, revision, and record maintenance.
• Support internal audits, external inspections, and regulatory compliance activities.
• Help identify GMP deviations, documentation errors, and non-compliance issues.
• Assist in tracking corrective and preventive actions (CAPA) and follow up on assigned quality actions.
• Maintain accurate records in accordance with data integrity and documentation requirements.
• Collaborate with Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs teams.
• Ensure compliance with applicable FDA regulations, cGMP guidelines, and internal quality procedures.
• Participate in GMP training and support continuous improvement initiatives.

Skills

GMP knowledge

SOPs familiarity

Batch records

CAPA

Documentation control

Attention to detail

Communication skills

MS Office

Regulatory compliance awareness

Data integrity basics

Education

Bachelor's or Master's degree in Pharmacy / Pharmaceutical Sciences / Biotechnology / Microbiology / Chemistry / Life Sciences

Tools

Microsoft Office

Job description

Industry: Pharmaceutical / Life Sciences

We are seeking a detail-oriented GMP Compliance Associate to support Good Manufacturing Practices (GMP) compliance activities within the pharmaceutical and life sciences industry. The candidate will assist with maintaining quality documentation, reviewing manufacturing records, supporting audits, and ensuring compliance with applicable regulatory requirements and company quality standards.

This role is suitable for candidates with a background in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, or other Life Sciences disciplines who are interested in quality assurance and regulatory compliance.

Key Responsibilities

• Support the implementation and maintenance of GMP procedures and quality standards.
• Review batch manufacturing records, standard operating procedures (SOPs), and other quality-related documents.
• Assist with document control activities, including document preparation, review, revision, and record maintenance.
• Support internal audits, external inspections, and regulatory compliance activities.
• Help identify GMP deviations, documentation errors, and non-compliance issues.
• Assist in tracking corrective and preventive actions (CAPA) and follow up on assigned quality actions.
• Maintain accurate records in accordance with data integrity and documentation requirements.
• Collaborate with Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs teams.
• Ensure compliance with applicable FDA regulations, cGMP guidelines, and internal quality procedures.
• Participate in GMP training and support continuous improvement initiatives.

Required Skills

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, or a related Life Sciences field.
• Basic understanding of Good Manufacturing Practices (GMP) and cGMP requirements.
• Familiarity with SOPs, batch records, quality documentation, and document control principles.
• Basic knowledge of deviation management, CAPA, and quality assurance processes.
• Strong attention to detail and organizational skills.
• Good written and verbal communication skills.
• Ability to maintain accurate records and follow established procedures.
• Proficiency in Microsoft Office applications, including Word and Excel.
• Willingness to learn pharmaceutical quality systems and regulatory requirements.
• Fresh graduates and candidates with 0-2 years of relevant experience are encouraged to apply.