Description
\t\t\t\t\tResponsible for batch record reviewAssess CMO batch compliance with FDA and ICH regulationsSupport investigations and deviationsReview and approve documents including: CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations and OOS in support of product releaseSupport and prepare for inspection readiness
\t\t\t\t\tSkills
\t\t\t\t\tQuality assurance, Batch Record Review, CMO, CAPA, Investigation, Deviation, OOS investigation, FDA, ICH, Compliance, GMP
\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality assurance,Batch Record Review,CMO,CAPA,Investigation,Deviation,OOS investigation
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tBS/MS in Biology discipline and 4+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulationsSupporting GMP Operations
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $70.00 - $81.00
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 hybrid 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 & InclusionAt 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 peopleThe 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.