QA Advisor III (life sciences experience required)

Resolian; Malvern (Chester County); On-site; USD 95,000 - 125,000; Full time

Job summary

Resolian in Malvern, PA is seeking a senior QA auditor to independently audit system trails, author SOPs, and support sponsor audits. You will lead vendor qualifications and internal audits, track quality metrics, and contribute to process improvements while training staff.

Ideal candidates have a BA/BS or higher and 6+ years in a GxP environment, with strong regulatory knowledge and documentation skills. The role requires collaboration in a fast-paced biotech setting and on-site work in Malvern.

Qualifications

• BA/BS or higher; all experiences will be evaluated.
• 6+ years experience in GxP Environment, all experiences will be evaluated.
• Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP.
• Familiar with pharmaceutical or biotechnology industry.
• Able to review detailed data and documents.
• Able to work effectively and contribute within a team.
• Able to work with computer systems.
• Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment.

Responsibilities

• Audit system audit trails accurately and independently.
• Author and review draft templates and SOPs.
• Host and participate in Sponsor audits as required.
• Perform vendor qualifications and audits with minimal oversight.
• Execute internal audits/self-inspection programs on schedule.
• Participate in process improvement initiatives.
• Track and present quality metrics with minimal oversight.
• Support delivery of quality training for employees as needed.
• Train new staff members independently as needed.
• Support quality events (deviation investigations, OOS, Change Control and CAPAs) to completion.
• Review procedures (e.g., SOPs) to improve quality and efficiency.

Skills

GxP Compliance

Audit leadership

Regulatory knowledge

Data analysis

Documentation

Education

BA/BS or higher

Job description

• Independently and accurately audits system audit trails
• Effectively authors and independently reviews draft templates and SOPs
• Actively participates and/or hosts Sponsor audits as required
• Effectively perform vendor qualifications and audits with minimal oversight
• Effectively executes internal audits/self-inspection programs against agreed upon schedules
• Independently participates in process improvement initiatives
• Accurately tracks and presents quality metrics with minimal oversight
• Actively supports delivery of quality training for employees as needed
• Independently and effectively executes training of new staff members as needed
• Actively supports quality events (deviation investigations, OOS, Change Control and/or CAPAs) to completion
• Effectively assists in the review and evaluation of procedures (e.g. SOPs) to improve quality and efficiency

Education, Experience & Skills Required:

• BA/BS or higher; all experiences will be evaluated
• 6+ years experience in GxP Environment, all experiences will be evaluated
• Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
• Familiar with pharmaceutical or biotechnology industry
• Able to review detailed data and documents
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment