Batch Record Reviewer

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

7d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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

Benefits

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.