Documentation Specialist

HIKMA • Bedford, OH

2d • Onsite

About The Position

We are seeking a talented and motivated Documentation Specialist. In this role, you will be responsible for processing and reviewing executed batch records in Operations. Batch records must be reviewed for accuracy in compliance with cGMP, FDA regulations and policies. Additional responsibilities will include assisting in update/revisions of manufacturing Standard Operating Procedures and the tracking of the document approvals through the VEEVA document system.

Requirements

• Minimum: High School diploma or equivalent is required.
• One or more years’ experience in healthcare/pharmaceutical product manufacturing or quality assurance.
• Strong background in pharmaceutical documentation and strong knowledge of cGMPs/FDA regulations
• Ability to write, revise and review SOPs
• Strong interpersonal skills and great attention to detail are necessary
• Proficient in Microsoft Office applications (Word and Excel)
• Good communication skills both verbal and written
• Good time management skills and the ability to multitask and work independently
• Strong ability to cope with the stress associated with changes in the daily production schedule
• Must have history of strong documentation skills and attention to detail.
• Familiarity with cGMPs and CFR.
• Good organizational skills and ability to multi-task and perform work in a timely manner.
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel.
• Basic knowledge of computer systems at a proficient level to navigate input and/or reference computerized data.
• Ability to read and understand documents such as production batch records, safety rules, corporate guidelines and standard operating procedures.

Nice To Haves

• Preferred: Associate of Science

Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Accurately review and approve executed production batch records and associated batch related documents.
• Accurately arrange the documents in a batch record.
• Revise/update Standard Operating Procedures pertaining to the Operations group.
• Maintain acceptable cGMP and Safety training level. This includes maintaining Job specific curriculum training at least 95% complete, attending and passing cGMP training sessions.
• Assist the Operations department in deviation investigation through documentation of findings

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED