What are the responsibilities and job description for the Document Associate I, QA position at Hikma Pharmaceuticals PLC?
Description:
Job
JOB PURPOSE
Review and approve GMP documentation to support timely product manufacture and release. Responsible for activities related to providing required documentation and implementing related documentation. Administers the document control process in relation to plant wide documentation changes as needed.
KEY ACCOUNTABILITIES
- Manage and maintain the official Document Change management system for creation, revision, and control of GMP documents. Create and maintain databases to track status of documents. Maintain original documents.
- Enter departmental training records into IsoTrain and provide monthly training completion reports. Enter information related to document changes into IsoTrain to enable “Read Only” training, “Interactive training” or no training.
- Drafts, reviews and word processes revised documents requiring revision or creation. Review and approves documentation for accuracy and compliance to procedures. Link appropriate document changes circulating together.
- Create, manage and maintain logbook indexes and all logbooks.
- Responsible for control and maintenance of the QA Documentation file room. Maintain and approve the official list of Approver Designees.
- Monitor the Doc Center to move documents as needed to ensure signatures are obtained in an efficient timeframe.
- Monitor and follow-up on biennial review of documents and other time sensitive project related documents.
- Complete weekly distribution of documents and reconcile superseded document returns after distribution.
QUALIFICATIONS
- Minimum: BS or BA degree with previous experience in pharmaceutical manufacturing.
EXPERIENCE
- One or more years’ experience in pharmaceutical or healthcare product manufacturing or quality assurance.
- Background in pharmaceutical documentation and knowledge of cGMPs/FDA regulations
SKILLS
- Working knowledge of related business systems.
- Intermediate level desktop skills and document management (e.g. Microsoft Office) software skills.
- Must have excellent conceptual, analytical, written and verbal configuration skills.
- Ability to work under strict deadlines and changing priorities with minimal supervision.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- 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
Compensation:
- Base Salary: $48,250 to $ 80,000 annually. 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.
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
- ing 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.
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.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
Salary : $48,250 - $80,000