Quality Lab Associate III, Chemistry

Job

Location: Bedford, OH

Job Type: Full time

Req ID: 8552

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 750 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 8,500 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 Associate III, Chemistry to join our team. In this role, you will be responsible for providing support to Chemistry laboratory as technical Writer. Responsible for conducting Laboratory Investigations, Annual Product Reviews, trending data and errors and writing protocols and reports. Provide monthly metric reports to QA/QC management.

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API's,
• ing materials, packaging components and finished products.
• Conduct laboratory investigations with laboratory supervisors, review related data, interview personnel, recommend corrective actions and write reports.
• Prepare, review, and revise, as required, SOPs, protocols, reports, and other appropriate documentation for proper functioning of the department. Assists and writes protocols for method evaluations and other studies for new product tech transfer projects.
• Assist in training staff and assures training requirements are met and records are up to date.
• Assist in audits by providing answers to questions regarding laboratory investigations posed by any inspector.
• Participate in pro-active functions that impact the lab operations and production, increase efficiency, solve problems, generate cost savings and improve quality.

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:

Education: Bachelors’ Degree in Chemistry or related science with Analytical Chemistry or Laboratory coursework, with 5 years’ experience in a cGMP Chemistry Laboratory

Experience: The work-related experiences required include the execution of analytical methods, with supervision for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical Finished Products (FPs). The colleague must be able to perform compendia and non-compendia testing for multiple projects at one time.

Skills:

• Knowledgeable of quality control chemistry operations in the pharmaceutical industry
• Exceptional technical writing skills
• Proficient with Microsoft Word and Excel
• Exceptional organizational skills and ability to plan and implement resolutions to technical problems
• Familiarity with auditing techniques, interpreting regulations and quality systems
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negation skills
• Good project management skills

Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices

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.

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.