Quality Lab Associate III, Chemistry

Job Title:      Quality Associate III, Chemistry

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, starting 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.