Specialist, Lab Metrology

Job Title: Specialist, Lab Metrology

Location: Columbus, OH

Job Type: Full time

Req : 6913

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.

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 Specialist, Lab Metrology to join our team. In this role, you will be responsible for performing aspects of group activities, such as compliance, maintenance, and repair of laboratory instrumentation and all related documentation. Offers mentoring such as, training sessions, and troubleshooting techniques.

Writes and reviews departmental work instructions (WI’s). Identifies work instructions which require updates based on new processes, instrumentation, and regulatory requirements.

• Coordinates with management for content and to meet established timelines.
• Communicates with Scientists and gain buy-in for procedure updates.
• Build consensus with QLABS management and analyst for procedure harmonization.

Performs instrument calibrations and monitors the calibration program

• Maintains, performs, reviews, and schedules calibrations.
• Communicates directly with service engineers and Quality Laboratory management for impacted instrumentation.
• Identify root causes for instrumentation failures through impact assessment process with laboratory management.
• Communicate with Flow lanes to document and complete CAPA’s.
• Receives quotes from vendors.

Reviews Installation Qualification, Operational Qualification, Performance Qualification (IQ OQ PQ).

Conducts instrument repairs to ensure working and efficient laboratories through trending and data analysis. Identifies instrumentation which are no longer reliable or able to be maintained.

• Shows initiative and proactively works with Flow lanes to determine which instruments to retire.
• Performs and/or coordinates repairs either individually, with a team, maintenance department, or with outside engineers.
• Maintains, reviews, and schedules in database.
• Communicates directly with service engineers.
• Able to trouble‑shoot in a timely and effective fashion to enable labs to meet deadlines.

Mentors analysts on new or improved instrumentation and techniques To ensure growth and development of analysts as well as compliance.

• Trains required individuals and provides input on training modules for new/revised equipment.
• Prepares materials such as one point lessons.

Identifies opportunities for improvement in laboratory instrumentation to ensure working efficient laboratory.

• Performs needs assessments with QLABS and Analytical Development for new technologies.
• Based on data available provides recommendations to management for new equipment purchases and drafts justification for purchase (APR).
• Drives cost‑savings in the lab through thorough review of all instrument and service quotes.
• Must be familiar will most types of analytical instrumentation (HPLC, UV, GC) – theory, operation, and trouble shooting.
• Extremely strong problem‑solving skills and able to make general repairs to all types of laboratory equipment.
• Strong computer skills – able to learn new software on the fly, troubleshoot basic computer problems. Set up and interface computer systems with lab instrumentation.
• Strong communication skills – written and oral – with the ability to teach and convey technical knowledge and develop training materials for others to use.
• Knowledge of GMP regulations, analytical instrument qualification, calibration, and DP requirements.