Biologics Quality Assurance Auditor

About the role

The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture and facility operations. This role works in conjunction with the Quality Assurance Manager to plan, schedule, and conduct audits and administrative tasks to support the quality management program.

Responsibilities

• Ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures, and expectations of phase appropriate current Good Manufacturing Practices (cGMP).
• Conduct a variety of quality improvement and process improvement initiatives as requested by the Quality Assurance Manager.
• Operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
• Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
• Lead data review processes to facilitate biologic IND product release.
• Perform GMP and Good Documentation Practices training for manufacturing and support personnel.
• Ability to lead QA functions related to the Quality programs such as process, laboratory audits, protocol approvals, etc. as assigned.
• Cook up vendor facility audits.
• Support the QA Manager in mentoring and training QA staff as needed.
• Support the QA Manager during client and regulatory audit, client audits for records review.
• Manage, review, and approve controlled documents including but not limited to SOPs, Methods, Test Protocols for the effective functioning of biologics manufacture, good tissue practices.
• Provide additional support to the Quality Assurance Manager as required.

Requirements

• Bachelor’s degree in scientific discipline with a minimum of 3 years quality or regulatory experience.
• Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP).
• Excellent computer skills required: Microsoft Office Suite, SharePoint, Quality Management Systems.
• Prior experience conducting audits, technical writing, SOP writing preferred.
• Ability to guide and train QA staff in various tasks.
• Ability to travel for vendor/supplier audits and trainings (approx. 15%).
• Strong interpersonal, organizational, leadership skills.
• Must be able to handle multiple tasks simultaneously in a growing department.
• Strong computer skills.

Qualifications

• Must have a Bachelor’s degree in a scientific discipline.
• Minimum of 3 years of quality or regulatory experience.
• Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP).
• Excellent computer skills: Microsoft Office Suite, SharePoint, Quality Management Systems.
• Prior experience conducting audits, technical writing, SOP writing preferred.
• Ability to guide and train QA staff in various tasks.
• Ability to travel for vendor/supplier audits and trainings (approx. 15%).
• Strong interpersonal, organizational, leadership skills.
• Must be able to handle multiple tasks simultaneously in a growing department.
• Strong computer skills.

Skills

• Good understanding of FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
• Experience in leading QA functions related to the Quality programs such as process, laboratory audits, protocol approvals, etc.
• Ability to operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
• Strong ability to lead and mentor QA staff.
• Excellent communication and interpersonal skills.
• Ability to manage and review controlled documents.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Pay and Benefits

The pay range for this position is $28.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Columbus, OH.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.