Sr. QC Analyst

Technical Operations San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

The Treatment Solutions Manager (“TSM”) will be responsible for promoting, educating, and contracting of iovera°, a novel device that provides immediate and long lasting relief of acute and chronic pain through cryoneurolysis of peripheral nerves.

Summary:

The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products.  In addition, may also develop, validate and/or optimize analytical methods.

 Essential Duties & Responsibilities:

  • The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.
  • Carry out product testing and stability studies, as needed.
  • Perform troubleshooting and preventive maintenance of laboratory equipment.
  • Write documents for regulatory submissions such as standard test methods, validation reports, and SOPs.
  • Provide technical assistance and training to other laboratory personnel.
  • Understand and comply with all company policies, safety procedures, and SOPs, including cGMPs and cGLPs.
  • Prepare analytical data for internal and external meetings and presentations.
  • Conduct laboratory tests in compliance with established Standard Test Methods, compendial methods and vendor/partner methods.
  • Maintain organized records of tests performed and results obtained following company policies
  • Assist in performing laboratory investigations.  Write investigation report as required.
  • Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
  • Lead in the transfer of methods to/from the Quality Control department.
  • Represent functional area in Project Teams, as required.
  • Mentors others, leads and coaches by example through examples of how to do the right thing and do it more efficiently.
  • Test and release of finished product for US Commercial and Clinical use.
  • Test and release of finished product for EU Commercial and Clinical use prior to final QP Certification of batches for EU distribution.
  • Test and release of Raw Materials for US and EU Commercial and Clinical use.

 Supervisory Responsibilities:

This person may have supervisory/leadership responsibilities.

 Interaction:

The incumbent works closely with all functional areas in Research and Development, Manufacturing, Quality Assurance, Document Control and Regulatory Affairs.

 Education and Experience:

 4-6 years of relevant hands-on laboratory experience.

  • BS degree in Chemistry from an accredited college or university or a combination of equivalent education and applicable job experience. 

 Qualifications:

 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 Knowledge, Skills, and Abilities: 

  • Demonstrated strength in analytical chemistry knowledge with special expertise in one or more analytical techniques (HPLC or GC) or special knowledge in one area (Liposomes or Raw Materials).
  • Demonstrated computer proficiency in word processing, spreadsheets, graphing.
  • Proficient in use of and well versed in the maintenance of most of the major laboratory instruments such as HPLC, GC, and mass spectrometry.
  • Advanced knowledge in some areas of cGMPs such as Change Control and Document Management.
  • Excellent observation skills and problem-solving abilities.
  • Ability to work in a methodical, organized, and creative fashion.
  • Ability to read, follow and under limited supervision, develop research protocols.
  • Ability to write in a concise and logical fashion in order to record all pertinent details of experimental procedures and data.  In addition, ability to write reports for internal circulation on scientific results generated.
  • Ability to effectively utilize scientific information resources within the assigned areas of responsibility.
  • Ability to work effectively, both independently, and as an integral contributor toward the achievement of project and company goals.
  • Ability to manage multiple responsibilities, with a high degree of self-motivation.
  • Excellent observation skills and good problem-solving ability.
  • Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant technical information.
  • Skilled at promoting team cooperation and a commitment to team success.
  • Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

 Job Scope:

 A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Normally receives little instruction on day-to-day work, general instructions on new assignments.

 Physical Demands: 

The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

 While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.  Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.  Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 

Typical office setting with a laboratory, offices and cubicles. Employee is required to work in the lab area. Noise level is moderate with consistent printer, telephone ringing and conversation.

 

EEO Statement:

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.