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 purpose of this position is to provide leadership, plan, direct, and coordinate the Quality Control in-process testing, finished product release testing and stability programs. Responsible for developing and maintaining QC policies and ensure quality and compliance in the QC laboratory.
Responsibilities:
Responsible for daily laboratory operations for QC Chemistry's finished product and stability programs including trending, scheduling, staffing, training and troubleshooting to ensure all operations are in full compliance with applicable SOPs and safety guidelines.
Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff.
Support the QC Chemistry team's responsibilities for the performance of all in-process, finished product and stability testing within the QC organization.
Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions.
Oversee the scheduling and execution of internal QC special studies, such as continuous improvement to the lab in regards to instrument and method life cycle management, as well as external special studies to support initiatives such as manufacturing and/or engineering process improvements.
Routinely interacts with internal and external colleagues, regulatory agencies, and internal auditors/inspectors.
Represent QC Chemistry at operational and cross-functional meetings; prepares and presents information, provides decision making support at meetings and disseminates information back to QC.
Responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands.
Oversee the test and release of finished product for US Commercial and Clinical use.
Oversee the test and release of finished product for EU Commercial and Clinical use prior to final QP Certification of batches for EU distribution.
As needed, support the test and release of Raw Materials for US and EU Commercial and Clinical use.
Qualifications:
S. or M.S. in science or technical field from an accredited college or university and relevant industry experience.
Minimum 10+ years of experience in pharmaceutical/Biotech industry or an equivalent combination of education and experience.
Experience in wet chemistry methods, chromatography methods and particle size testing.
Previous leadership or supervisory experience required.
Working knowledge of cGMP, regulatory compliance (US and other international agencies), and Agilent equipment and software.
Experience providing scientific input, data analysis and written reports for failure investigations.
Practical knowledge and sound understanding of methods development, validation and regulatory submission.
Effective oral, written, and interpersonal English communication skills.
Lead trouble shooting chemistry testing on a real time basis.
Ability to multi-task with good adaptability to changing business requirements in a dynamic
corporate and QC environment.
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.
