QC Compliance Scientist
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. Provide chemistry laboratory support such as, but not limited to, generating Laboratory Investigation reports, Laboratory exceptions, Responsibilities primarily involve working on Laboratory investigations with minimal supervision.
Requirements
- Computer literacy, technical writing, multi-tasking and work prioritization skills are required.
- Thorough understanding and proficient in the use of analytical glassware, syringes, pipettes, balances and other instrumentation.
- In-depth knowledge of lab techniques also required.
- Proficiency in the use of Microsoft Office including Word and Excel.
- Extensive experience in instrumental analysis, especially HPLC and GC.
- Experience in pharmaceutical formulation, analytical methods, research, problem-solving, and experimental design.
- Good communication skills, both oral and written.
- Ability to listen, accept instruction and execute tasks under pressure while maintaining a professional demeanor.
- Requires a bachelor’s degree in chemistry or closely related field and at least 5 years of pharmaceutical or related laboratory experience, or Master’s degree in chemistry or closely related field with 3 years of pharmaceutical or related laboratory experience.
Nice To Haves
- Project planning techniques and use of project planning software, a plus.
Responsibilities
- Accurate and timely maintenance of CLEs and LIR records.
- Lead laboratory investigations upon generation of Out of Specification or Out of Trend results.
- Actively involve in investigation, interview analyst, and identify root cause for out of Specification result.
- Initiate LIR and Test plan for Laboratory investigations.
- Generate Trend reports for the OOS’s generated based on root causes identified.
- Author on Annual Product Review reports and submit to QA compliance on monthly basis.
- Write Chemistry Laboratory Exception reports as needed.
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
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
