Quality Assurance Compliance -Hybrid

Candidate will aid in the design, preparation, implementation, and management of client quality systems. Review of existing systems, document review, general consulting and auditing for programs needed to comply with regulatory requirements of FDA and other regulatory authorities worldwide.

Note: This is an evergreen posting for future positions within our team. If you would like to be considered during the next round of hirings and have the qualifications, please apply.

Writes and reviews client compliance or QA SOPs
• Conducts quality system assessments under the direction of management
• Collaborates with clients to develop auditing and quality system procedures and standards
• Trains clients and other staff on regulatory compliance requirements and issues
• Provides basic auditing services
• cGMP document review, which may include batch records and/or validation protocols

• 5+ years experience with assessment, review, design, revision, and implementation of quality systems and documents
• Relies on extensive experience and judgement to plan and accomplish tasks and goals
• Detail orientated with excellent written and oral communication skills
• Ability to work independently to solve problems
• Motivated, efficient, self-starter skilled in time management

IND2