Job Title: Batch Record Review Specialist

Job Description

The Batch Record Review Specialist will be responsible for reviewing tickets in packaging areas, both sterile and non-sterile, ensuring that prep tickets such as autoclave loads, stoppers, and bulk packaging conform to company policy and cGMP standards. You will create, edit, and proofread batch records and product labels while checking for errors such as missing signatures, incorrect dates, and illegible writing. You will collaborate with Operations to update tickets and interface with systems like LRT, LIMs, SAP, PacOne, QTS, and PDOCs. Prompt escalation of issues with potential market or stability impact is essential, as is accurate communication of supply and operational needs and perspectives.

Responsibilities

• Review tickets for packaging areas to ensure compliance with policies and cGMP standards.
• Create, edit, and proofread batch records and product labels.
• Identify errors such as missing signatures, incorrect dates, and illegible writing.
• Collaborate with Operations to update tickets.
• Interface with systems including LRT, LIMs, SAP, PacOne, QTS, and PDOCs.
• Escalate issues with potential market or stability impact immediately.
• Communicate supply and operational needs and perspectives accurately.

Essential Skills

• Bachelor's Degree in a Life Science Major (Biology, Microbiology, BMS, Cell & Molecular, Biochemistry, etc).
• Computer literacy.
• Knowledge in life sciences.

Additional Skills & Qualifications

• Excellent organizational skills with ability to handle changing deadlines.
• Good communication skills to interact with all levels of customers.
• Attention to detail and accuracy.
• Ability to follow written and verbal directions and handle confidential documents.
• Understanding and following standard operating procedures.
• Ability to work independently and in a team environment.
• Self-motivated and adherence to performance metrics.
• Willingness to learn new and evolving responsibilities.
• Flexibility to respond to changing conditions and priorities.
• Independent response to routine and non-routine requests for information.
• Basic understanding of a manufacturing environment is preferred.
• Ability to learn and adhere to safety requirements in a manufacturing environment.
• Fluent knowledge of Microsoft Word and Excel.
• Knowledge of GMP requirements is preferred.

Work Environment

This position is office-based, running up through the Quality Organization. The work hours are from 8 am to 4:30 pm, during the first shift.

Pay and Benefits

The pay range for this position is $20.00 - $20.00/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 Kalamazoo,MI.

Application Deadline

This position is anticipated to close on Aug 15, 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.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $20