• Documentation Specialist

    Actalent (Buffalo, NY)


    Documentation Specialist

    Job Description

    The role of Documentation Specialist involves ensuring quality oversight and providing assistance with Inspection and Packaging processes at the manufacturing facility. This position is responsible for AQL sampling and product inspection, recommending corrective actions for deviations noted, and assuring compliance with SOPs and cGMPs while adhering to Good Documentation Practices.

    Responsibilities

    + Perform visual inspection of samples using AQL sampling for all product vial sizes and types.

    + Recognize opportunities for improvement and compliance, communicating them promptly to production colleagues and MQA Supervision.

    + Obtain and maintain Visual Inspector qualification for performing AQLs, subject to ongoing qualification training and testing.

    + Assure proper line clearances and quality assurance procedures within the Inspection and Packaging areas.

    + Ensure that packaged products meet the highest quality standards.

    + Serve as the cGMP 'go-to person' on the Inspection and Packaging floor.

    + Review batch record pages for proper documentation and on-line completion.

    + Verify completion of line clearances when necessary.

    + Ensure compliance with all SOPs and cGMPs.

    + Guarantee all operations on the Inspection and Packaging floor are performed as required by written procedures, with critical steps executed as directed in SOPs and batch records.

    + Maintain a safe working environment, wearing appropriate safety equipment and apparel at all times, and alert the supervisor to any unsafe conditions.

    + Perform other duties as assigned, including working overtime as needed.

    + Ensure compliance to company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management System.

    Essential Skills

    + Document control

    + Quality assurance

    + Sample management

    + Data entry

    Additional Skills & Qualifications

    + Bachelor's degree in Life Sciences or related field preferred.

    + Minimum of High School Diploma with 1-3 years of related experience required.

    + Broad production knowledge is a plus.

    + Some computer skills helpful.

    + Visual inspection experience

    + QA experience

    + Microsoft program experience

    + Experience in the pharmaceutical industry is desired but not mandatory.

    Work Environment

    The work environment includes lab, office, and manufacturing settings. The position follows a 5th Shift schedule, working Friday, Saturday, and Sunday from 6:00 pm to 6:30 am. Dress code requires appropriate safety equipment and apparel to ensure a safe working environment.

    Pay and Benefits

    The pay range for this position is $22.00 - $22.00/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 Buffalo,NY.

     

    Application Deadline

     

    This position is anticipated to close on Jun 11, 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 [email protected] (%[email protected]) for other accommodation options.