Sr. Quality Systems Engineer
 Pacira BioSciences, Inc. | |
life insurance, flexible benefit account, parental leave, paid holidays, flex time, 401(k)
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 United States, California, San Diego | |
| 10450 Science Center Drive (Show on map) | |
 Feb 28, 2025 | |
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Overview
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.
Responsibilities 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 software and potential hardware modifications to the system(s) using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
* Administer and Maintain the Master Control system to support GxP compliance, ensuring its effective operations and alignment with global regulatory, privacy, ethics and compliance requirements.
* Participate in testing and assisting/executing validation test scripts in Master Control/Compliance wire and other Systems
* Implement Software Quality Assurance practices in all system upgrades and ongoing projects. Review, execute, and draft software-related Installation Qualification (IQ) and Operational Qualification (OQ) protocols as needed.
* Create and maintain reports in Master Control/Compliance Wire.
* Participate with department teams to gather necessary requirements for maintaining Master Control/Compliance Wire and for other Systems as needed.
* Create and maintain operational procedures relevant to the applications and train 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.
* Create and maintain a Quality Matrix with a focus on continuous improvement. Author, review and revise QMS policies and procedures.
* Participate in internal and external audits and addressing questions related to Systems
* 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.
* Handle multiple assignments simultaneously; effectively prioritize tasks and meet strict deadlines while maintaining high standards, accuracy and efficiency.
Supervisory Responsibilities:
This position does not have supervisory responsibilities.
Qualifications Education and Experience:
* BS/BA in Computer Science, Information Technology or equivalent discipline required
* 8 Years relevant experience with Quality Assurance
* 5 Years of Quality Systems experience required; Master Control experience preferred
* Internal and external audit experience preferred
* Software quality experience preferred
* 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 or similar system preferred
* 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
* Good problem solving and decision-making skills
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
Pay Transparency The base pay range for this role in California is $120,000 per year to $160,000 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.
EEO Statement 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. | |