Aseptic Processing Area Support - Summer Intern

Nature and Scope

Seeking a detail-oriented and highly organized professional to support documentation and compliance activities within the Aseptic Processing Area (APA). The APA Support Intern will ensure the accuracy, completeness, and compliance of critical production records, assist with production yield tracking, and support cost accounting processes. This role requires strong attention to detail, the ability to collaborate with cross-functional teams, and a commitment to maintaining regulatory and procedural compliance.

This role offers an opportunity to contribute to the integrity of critical manufacturing processes while developing expertise in regulatory compliance and documentation management.

This internship program will require you to be in our Shirley, NY office 5 days per week, working 40 hours per week in a manufacturing production environment.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Support the preparation and maintenance of Aseptic Processing Area (APA) documentation.

• Review Batch Intervention Reports to ensure accuracy, completeness, and compliance with regulatory and company standards.

• Assist in tracking production yields to monitor efficiency and accuracy in production processes.

• Facilitate personnel label ticket processing for Cost Accounting to ensure proper documentation and reporting.

• Provide supporting documentation for Notices of Events (NOEs) to assist in investigations and regulatory reporting.

• Scan and upload training records to the designated Training folder, ensuring proper record-kehttps://secure.echosign.com/public/logineping and accessibility.

• Verify accuracy and compliance of area logbooks, ensuring all entries align with company guidelines and regulatory expectations.

• Prepare SDA and bleach expiration labels in accordance with established procedures and guidelines.

• Perform additional tasks and duties as assigned by management to support APA operations and compliance.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 1+ years of college level courses pursuing a degree in an accredited Business, Data Science, or Data Analytics program required.

• Experience in documentation control compliance preferred.

• Strong attention to detail and ability to maintain accurate records.

• Proficiency in data entry, record management, and Microsoft Office Suite.

• Strong organizational and communication skills.

• Ability to work collaboratively in a team-oriented environment.

• Understanding of Good Manufacturing Practices (GMP) and regulatory requirements (preferred).

• Knowledge of aseptic processing or pharmaceutical manufacturing is a plus.

Physical Environment and Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Hourly Rate:

$18.50 - $20.00

The hourly rate rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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