Documentation Specialist

RXinsider LTD.; Bedford (OH); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Annual bonus

401(k) program

PTO

Holidays

Health benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Documentation Specialist in Bedford, Ohio to review and approve batch records and support GMP-compliant documentation processes. The role involves organizing batch records, updating SOPs, and ensuring training compliance.

Strong attention to detail and familiarity with cGMP/FDA regulations are essential for success. The position is full-time onsite with comprehensive benefits, opportunities for growth, and cross-functional collaboration across the

Qualifications

• High School diploma or equivalent required.
• Associate of Science preferred.
• 1+ year experience in healthcare/pharma manufacturing or QA preferred.
• Strong knowledge of cGMP and FDA regulations.

Responsibilities

• Review and approve executed production batch records and related documents.
• Arrange documents within a batch record accurately.
• Revise/update SOPs for Operations.
• Maintain cGMP training and complete required training (95%+).
• Assist in deviation investigations through documentation of findings.

Skills

SOP writing

Attention to detail

Communication skills

Time management

Teamwork

cGMP/FDA knowledge

Documentation

Education

High School diploma or equivalent

Associate of Science

Tools

Microsoft Word

Microsoft Excel

Job description

Job Title: Documentation Specialist

Location: Bedford, Ohio

Job Type: Full-time

Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. 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.

Key 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

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

Education:

• Minimum: High School diploma or equivalent is required.
• Preferred: Associate of Science

Experience:

• Minimum:
• 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

Skills

• 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.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.