Description

Provide quality oversight of Sarepta’s Blue Mountain application for induction, calibration and maintenance of all lab equipment and instrumentation

• Collaborate with lab systems owners on the induction and/or qualification activities of lab assets

• Adhere to regulatory guidance, policies, and procedures for qualification, and validation of Lab equipment and instrumentation

• Use risk management principles for qualification and remediation efforts

Skills

Validation, blue mountain, gene therapy, biologics, Validation protocols, Quality assurance, Gmp, FDA, EMEA, ICH

Additional Skills & Qualifications

8-12 years of relevant experience and bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred

• Direct experience in qualification and validation using FDA, EMEA and ICH guidance required.

• Experience with qualification of lab equipment and validation of processes associated to manufacture of clinical and commercial products highly desirable

Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally

• Knowledge of biologics/gene therapy processes desirable

• Prior QA experience highly desirable

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $50.00 - $60.00

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 Andover,MA.

Application Deadline

This position will be accepting applications until Dec 30, 2024.

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.