Documentation Specialist

About the role

We are seeking a talented and motivated Documentation Specialist to process and review executed batch records in Operations. Batch records must be reviewed for accuracy in compliance with cGMP, FDA regulations, and company policies. You will also assist in updating and revising manufacturing Standard Operating Procedures and track document approvals through the VEEVA document system.

Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Accurately review and approve executed production batch records and associated documents.
• Arrange documents in a batch record with precision.
• Revise and update Standard Operating Procedures for the Operations group.
• Maintain acceptable cGMP and Safety training levels, including job-specific curriculum training at least 95% complete.
• Attend and pass cGMP training sessions.
• Assist the Operations department in deviation investigations through documentation of findings.

Qualifications

• Education: Minimum: High School diploma or equivalent (required). Preferred: Associate of Science.
• Experience: Minimum: One or more years in healthcare/pharmaceutical product manufacturing or quality assurance.

Skills

• Ability to write, revise, and review SOPs.
• Strong interpersonal skills and great attention to detail.
• Proficient in Microsoft Office applications (Word and Excel).
• Good verbal and written communication skills.
• Strong time management and ability to multitask and work independently.
• Ability to cope with stress associated with changes in the daily production schedule.
• History of strong documentation skills and attention to detail.
• Familiarity with cGMPs and CFR.
• Good organizational skills and ability to perform work in a timely manner.
• Ability to work in a team environment and communicate effectively with peers, management, and production personnel.
• Basic knowledge of computer systems to navigate, input, and reference computerized data.
• Ability to read and understand production batch records, safety rules, corporate guidelines, and standard operating procedures.

Pay

Hourly Rate: $21.00 per hour. Compensation may vary based on factors such as work location, prior experience, job-related knowledge, skills, and current business needs.

Benefits

• Annual performance bonus, commission, and share potential.
• Auto-enrollment in a Hikma-sponsored 401(k) program with a 3% pre-tax contribution; Hikma matches 100% of the first 6% of eligible pay.
• Generous paid time off (PTO) starting with 20 days (prorated based on hire date), plus additional days granted upon 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 voluntary benefits.
• Employee discount program.
• Wellbeing rewards program.
• Career advancement and growth opportunities.
• Tuition reimbursement.
• Paid maternity and parental leave.

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