Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Compliance Specialist is responsible for auditing and maintaining robust quality systems and procedures in support of GMP activities. This position supports internal and external audit programs to ensure Quality standards and business expectations are met. You will work directly with external partners and internal resources to assure compliance with GXP regulations and continuous improvement of Quality Systems.

Responsibilities

• Serve as a representative on cross-functional project teams and represent the quality organization both internally and externally.
• Support GMP readiness activities for the new manufacturing facility, laboratories, and support areas including system development and implementation.
• Support implementation and routine management of core Quality Systems.
• Interpret regulations and guidance documents and apply to practical situations.
• Provide QA support for raw material item approval, receipt, and test specifications.
• Conduct and participate in scheduled audits of suppliers.
• Manage supplier audit schedules, communicate with suppliers as needed to ensure audit CAPA completion and audit close-out.
• Generate, review, and implement procedures as needed.
• Independently plan and perform assigned responsibilities and projects with minimal supervision.
• Lead development of quality and other related business processes.
• Perform quality transactions in inventory management systems for GXP materials.
• Provide QA support for risk identification, assessment, and remediation.
• Promote a culture of quality and operational excellence.

Essential Skills

• Minimum of 8 years’ experience in a GMP regulated function in gene therapy/biopharma/biologics, with a minimum of 4 years in Quality Assurance.
• Bachelor’s degree or greater in a scientific discipline.
• Experience performing Quality audits.
• Ability to build strong collaborative relationships with partners in and outside the organization.
• Ability to manage and prioritize workload to meet aggressive timelines and changing priorities.
• Excellent attention to detail.
• Working knowledge of FDA and EU GMP regulations as well as ICH guidelines.
• Experience using electronic quality systems to monitor, report, and track quality tasks and key quality performance indicators.
• Proficient use of MS PowerPoint, Excel, and Word.
• Strong communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
• Demonstrate a deep understanding of biologics manufacturing – process, analytical, operations, quality systems, regulations.
• Working knowledge of relevant GXP regulations and supporting guidelines.
• Ability to communicate clearly, both written and oral.
• Strong organizational skills.
• Ability to identify and assess issues related to process/procedure execution, determining technical and compliance impact and appropriate action.

Additional Skills & Qualifications

• Experience using electronic quality systems to monitor, report, and track quality tasks and key quality performance indicators.
• Proficient use of MS PowerPoint, Excel, and Word.
• Strong communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
• Excellent attention to detail.
• Ability to manage and prioritize workload to meet aggressive timelines and changing priorities.

Work Environment

This position operates in both cleanroom and office environments.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/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)

Workplace Type

This is a fully onsite position in ROCKVILLE,MD.

Application Deadline

This position is anticipated to close on Feb 20, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $65