Position Summary

The Compounder Helper/Batch Reviewer’s primary responsibility concerns manufacturing batch record control and review. This includes collection, review, correction and data collection around the process. Secondarily, the Compounder Helper/Batch Reviewer will assist with SOP/WKI training and be assigned other duties assisting the Lab Managers. These responsibilities include ensuring all work is performed in compliance with Safe Work Practices, cGMP, Standard Operating Procedures, Company policies and strategy. They must demonstrate leadership particularly in the area of coaching, ability to handle multiple priorities in a fast-paced environment and ability to contribute to the improvement of departmental KPIs.

Together with the department leadership team, the Compounder Helper/Batch Reviewer will assist with GDP/GMP performance evaluation, team development and training. They willprovide results-oriented leadership that drives continuous improvement consistent with the Operations Strategy. They will coordinate, assign, lead and manage certain departmental activities, administrative and other, ensuring agreed-upon goals and objectives are met.

After training, they are expected to demonstrate extensive knowledge of departmental proceduresand systems operations. They are expected to demonstrate ability to apply knowledge and experience to meet and exceed job requirements.

KEY ROLES & RESPONSIBILITIES

Document Review

• Conduct documentation reviews within the Compounding Department for compliance with existing procedures and instructions. Verify the effectiveness of procedures and instructions versus Company requirements and needs.

• SOP/OPS/WKI creation, modification and management.

• Perform review of executed batch records.

• Scan and file executed batch records.

• Coordinate with Office Services and Iron Mountain when batch records are requested or need to be submitted.

• GDP performance tracking, GDP training.

• Escalate critical issues to Operations/Quality Leadership as required.

• Coordinate with the QA Specialists when batch cards are reviewed and ready for final approval from QA.

Learning and Development

• Training, training documentation and management for the Compounding Department.

• Maintain all Employee training records:

o File all True copies of the training records in employee folders.

o Place all Original training records in the appropriate binders.

COMPETENCIES

• Excellent communication skills and ability to collaborate cross-functionally.

• Demonstrated ability to work in a fast pace, results-oriented environment, must be able to work with a sense of urgency to drive effective business results.

• Strong coaching and training capability. Ability to thoroughly understand Company-wide and departmental procedures. Ability to train and monitor performance against those procedures.

• Proficient in MS Office (Word, Excel, Outlook, PPT) and SAP preferred.

• Ability to interpret and assess operational compliance against Good Manufacturing Practices.

• Ability to review SOP’s, WKIs, OPIs, batch records, other official documentation.

• Familiarity with Good Manufacturing Practices and controlled Manufacturing Environment rules and expectations.

Qualifications

Minimum Education Level: High School or equivalent

Minimum Years of Experience: Minimum 2-year experience in manufacturing environment

Additional Job Specifications: Experience with MS Office and SAP preferred. Excellent communication and interpersonal skills. English language proficiency. Must maintain a good attendance record.

Job: Manufacturing - Supply Chain
Primary Location: US-NY-Melville
Job Type: Standard
Schedule: Full-time
Shift: 1st (Day) Shift
Job Number: 2218589

We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.