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.

Summary:

This position provides high level technical quality engineering support and development of the QMS, Training and other Quality related applications.

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.

Create and maintain system user groups, roles, workflows and curriculums in Master Control.
Create software and potential hardware modifications to the system(s) using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
Participate in testing and assisting/executing validation test scripts in Master Control.
Create and maintain reports in Master Control/Compliance Wire.
Participate with department teams to gather necessary requirements for maintaining Master Control/Compliance Wire as needed.
Create and maintain operational procedures relevant to the applications and trains the departments as necessary with respect to any changes.
Maintain application knowledge, including staying current on software capabilities and availability of new functionality and updates from the software vendor.
Assist, maintain, and update the test protocols.
Assist in creating and maintaining Quality Matrix.
Author, review and revise QMS policies and procedures.
Participate in internal and external audits as required.
Act as the point of contact for technical support, ensuring accuracy and completeness of data; implement improvements; establish and maintain security and integrity controls.
Engage and work with application software vendors and/or consultants to further configure the system, deploy functional enhancements and correct configuration issues
Provide incident diagnosis and support business users in the management and timely resolution of technical incidents.
Perform other duties as assigned.

Supervisory Responsibilities:

This position does not have supervisory responsibilities.

Education and Experience:

BS/BA in Computer Science, Information Technology or equivalent discipline required
8 Years relevant experience with Quality Assurance/Quality Systems required
5 years' experience in Master Control required
Experience in the pharmaceutical or biotechnology industry preferred

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:

Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliances
Familiarity with GxP best practices and GMP Compliant Change Control process
Expert in creating reports in Master Control
Must possess strong knowledge of systems development life cycle, application development or systems integration
Ability to work with cross functional teams to solve quality problems
Knowledge of SQL, JQuery and Crystal Reports desirable.

Physical Demands:

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. Commonly lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment:

Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.

Benefits:

Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental Leave

The base pay range for this role in California is $96,000 per year to $132,000 per year.

The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.