Title:  Document Associate, QA

Job Title: Documentation Specialist

Location: Bedford, Ohio

Job Type: Full-time

Job ID: 10792

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE 

• Responsible for Document control, issuance and retrieval of controlled copies of documents in the Bedford manufacturing site.

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Author / Revise/approve Standard Operating Procedures pertaining to the Doc. Control.  
• Ensure that GMP documentation is created, approved, and filed in accordance with company and regulatory requirements.
• Issuance and archival of Controlled copies of documentation, like Batch Production Records, Logbooks, etc
• Acts as a business user for electronic document management system (Veeva) and complete the necessary training related.
• Liaise with functional groups within the facility to assist in creation, tracking and control of documents to ensure consistency within document control system.
• Supports Audit Preparation activities and assist with document request and follow-up activities
• Responsible for all other documentation control related responsibilities for Site CLE.
• Coordinate daily workload

QUALIFICATIONS

• Minimum: Associate degree, Sciences or related field; previous pharmaceutical experience with a degree in another field may also be considered.
• Preferred: Degree in science or related field

EXPERIENCE

Minimum:   

• One or more years’ experience in pharmaceutical or healthcare product manufacturing or quality assurance
• Strong background in pharmaceutical documentation and strong knowledge of cGMPs/FDA regulations
• Preferred: Experience in Pharmaceuticals Doc Control and electronic document management system

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

Compensation:

Hourly Rate: $ $22.60 to $38.00. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma

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.