Title:  Batch Record Reviewer

Job Title: Batch Record Reviewer

Location: Cherry Hill

Job Type: Full-Time

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 :

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 Batch Record Reviewer to join our team.  In this role, you will be responsible for esponsibility for Batch Record Review daily. Batch Records must be reviewed for accuracy and consistency of documentation. Internal SOPs/ Job aids are used for reference to determine if documentation is appropriate. Review must include confirmation that all batch record instructions are met and are documented appropriately in order to reconstruct the manufacture of each specific lot. Batch Record review will include review of validation lots, media fill lots, commercial production lots and submission batches. Additionally,

this position is also responsible for reviewing the Autoclave loads, Drying loads, Equipment prep modules, Girton and Creast Ultrasonics washer load, Fedegari load sheets, Tunnel charts, Cleaning solution BR and other batch record related documents.

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality
• Accurately review all available batch records within the three days of receipt to assure compliance with cGMPs and internal SOPs. Maintain a review accuracy of 100% for all critical errors and at least 95% accuracy for non-critical errors. Maintaining a working relationship with factory management is necessary in order to process corrections and provide timely customer service through product release.
• Accurately review Autoclave loads, Drying loads, Equipment prep modules, Girton and Creast Ultrasonics washer load, Fedegari load sheets, Tunnel charts, Cleaning solution BR and other batch record related documents.
• Enter all batch record review data into LIMS system and provide appropriate documentation for final release . Assist in assuring batches are not released without the completion of the appropriate documentation
• Maintain acceptable cGMP and Safety training level. This includes maintaining Job specific curriculum training at least 90% complete, attending and passing assessments for all monthly safety meetings and quarterly cGMP training sessions
• Decisions made by Batch Record Reviewers affect the release of acceptable unadulterated materials. This position assures appropriate documentation is in place to represent the lot manufacture, including review of Media and validation lots
• Ability to release lots in different systems when the lot is deemed acceptable.
• Ability to accurately arrange the documents in a batch record.
• Create Certificate of Analysis when required by a customer.
• Revise SOP’s or related Job Aids when assigned.
• Self-motivated to check training requirements for themselves in IsoTrain

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:

• Minimum: Associates Degree with 2-4 years applicable laboratory, pharmaceutical manufacturing or related experience

Preferred Qualifications:

• Preferred: Bachelors’ Degree  with 0-2 years applicable laboratory, pharmaceutical manufacturing or related experience 

Compensation:

Base Salary: $56,950 to $ 95,000 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 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.

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.