Pharmaceutical Manufacturing Documentation Specialist

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POST DATE 8/27/2016
END DATE 1/25/2017

US WorldMeds Louisville, KY

Louisville, KY
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Associates Degree



At US WorldMeds, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet medical needs.

US WorldMeds' commitment to patients is reflected in all that we do. We are a company driven by the knowledge that our work is important; we have the desire to make a difference. We offer our employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.

Job Skills / Requirements

The Documentation Specialist is responsible for Quality department administrative support in the form of audit scheduling, travel arraignments, logistical support for Quality department personnel while traveling to and from CMO, CLO, and Supplier audits. Administrative support as requested by Quality Department management as well as support document control functions in the form of change controls, deviations, investigations, OOS, corrective and preventive actions (CAPA) and training.
The following reflects Quality managements definition of essential functions for this job but does not restrict the tasks that may be assigned. Quality management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation, business needs, or other reasons.
Responsible for assisting Quality personnel in scheduling internal and external audits, including contacting CMO, CLO, Suppliers, etc.
Responsible for providing support to Document Control lead in the form of filing, ensuring documents are organized in an efficient manner for ease of retrieval during audits or inspections.
Responsible for supporting regulatory inspections/being part of the team that supports inspections.
Responsible for preparing, and proofing procedures, forms, reports, and other documents as requested by Document Control Lead and/or Quality management.
Responsible for liaising with CMOs, CLOs and other third parties as requested to obtain information, documentation, or other data to ensure audit files, document control files, and inspection files are complete.
Associates Degree or Bachelor's degree.
Minimum 2 years of experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry.

Education Requirements (All)

Associates Degree
Bachelors Degree

Additional Information / Benefits

US WorldMeds offers a competitive benefits package, including Medical, Prescription, Dental and Vision coverage, 401(k), Life and AD&D, Short and Long Term Disability, Long Term Care, and paid time off.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

This job reports to the Senior Director, Quality

This is a Full-Time position 1st Shift.

Relocation is not provided and travel is not required

Number of Openings for this position: 1