Job Title: Quality Control Technical Writer
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’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
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 Quality Control Technical Writer to join our team. In this role, you will be responsible for the generation of technical documents such as Justification of Specifications, Elemental Impurity / Nitrosamine Risk assessments, initiate Laboratory Investigation Reports and Laboratory Exceptions, with minimal supervision. Additional responsibilities such as Annual Product Reviews, and various technical documents.
Key Responsibilities:
- Initiate laboratory investigations or Deviation 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. Perform quarterly review and generate reports for analytical procedures requiring remediation.
- Author and/or review Elemental Impurity and Nitrosamine risk assessments, as required.
- Author Justification of Specifications for RMQ, New in-coming component or Tech transfer activity related
- Author method Verification/ validation protocols and reports for chromatographic methods
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:
- Computer literacy, technical writing, multi-tasking and work prioritization skills are required.
- Thorough understanding of analytical glassware, syringes, pipettes, balances and other instrumentation.
- In-depth knowledge of lab techniques also required.
- In-depth knowledge of USP and ICH guideline
- Proficiency in the use of Microsoft Office including Word and Excel. Project planning techniques and use of project planning software, a plus.
- Experience with laboratory data systems, Empower, Labware, etc.
- 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.
Education:
- 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.
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 4% 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.
