Sr. Quality Systems Engineer
Job Description
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.
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.
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.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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