Job Description

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.

How You Will Achieve It

The analyst III-chemistry, will be to perform basic analysis for raw materials, in process, finished products, and/or TSR/validation/investigational testing in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality.

Report testing results through computerized systems, or through standard laboratory paper-based documentation.  Other related duties essential to these operations or special assignments as required.

Provides technical support as necessary to the assigned laboratory. Investigates, analyzes, problem solves, and communicates technical information to internal and external customers. Other related duties essential to these operations or special assignments as required.

Trains and supports inexperienced analysts, working as a Certified Fellow Employee and mentor to aid in their development as analysts.

• Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
• Follows procedures at all times, adopting cGMP, cGDP practices.
• Follows supervisor directions at all times.
• Able to function independently, but asks questions as necessary
• Accepts dynamic work sequences
• Must be self-motivated and work with minimal direction
• Must have strong technical and/or leadership skills
• Routinely participates in daily Shift Handover and/or CQ Performance huddles, including discussions on improving planning communication, and teamwork efforts in the CQ laboratory (where applicable for function).
• Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed
• Works with supervision and management to identify opportunities to improve testing efficiencies and actively participates in subsequent related projects
• Consistently communicates work sequence status to supervisor in a timely manner.
• Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement and actively works on efforts to recover adherence gaps
• Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals.
• When faced with roadblocks and issues, routinely offers suggestions for improvements and actively participates in associated improvement activities wherever possible
• Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift and across shifts wherever possible.
• Maintains an on-time training
• Must have strong organizational skills and an ability to multi-task across projects and activities.
• Demonstrate proficiency in computerized systems (Experience and use of LIMS, Empower are plus).
• Demonstrated ability to troubleshoot analytical methods
• Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter as wells as more advanced techniques, i.e. GC, HPLC, AA, FTIR, etc.

Qualifications

Must-Have

• High School Diploma or GED
• At least 6 years analytical laboratory experience in a GMP regulated environment
• Certification in assigned area, if applicable
• Ability to write clear technical document.
• Good organizational and time management skills
• Good oral and written communication skills
• Good Microsoft Office skills

Nice-to-Have

• BS/MS in Chemistry or BS Science Degree
• At least 6 years analytical laboratory experience in a GMP regulated environment or 4 years for MS/PhD
• Experience in parenteral drug product pharmaceutical manufacturing is plus.
• Successful hands-on analytical testing experience in a GMP environment.

PHYSICAL/MENTAL REQUIREMENTS

Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

There are no out of the ordinary travel or shift requirements associated with the position.   Individual will be expected to work nonstandard schedule as needed to support the business objectives

Work Location Assignment: On Premise

*Job Details:

· Last Date to Apply for Job: February 14, 2023

· Eligible for Employee Referral Bonus: Yes

· Schedule: First shift

· Relocation assistance may be available based on the business needs and/or eligibility

Relocation assistance may be available based on business needs and/or eligibility.