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QA Associate 1
San Diego, CA
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.
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.
Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.
We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!
We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
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.
Purpose:
This person is to assist and support the organization with GMP compliance, monitoring conformance to established quality assurance processes and GMP standards for manufacturing.
Responsibilities:
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP).
- Assist in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them.
- Facilitate internal training on quality assurance requirements, processes, and procedures.
- Monitor for GMP compliance of all in-process activities during GMP processing.
- Perform AQL particle inspection of in-process product vials prior to packaging.
- Perform review of executed Batch Documentation and prepare for disposition.
- Perform all process steps for the Transfer and Shipment of Batch Records with management oversight.
- Search and document quality event reports for Batch Release.
- Maintain databases as required.
- Perform other duties as assigned.
Supervisory Responsibilities:
This person has no direct supervisor responsibilities.
Interaction:
Continuously interacts with other members of the Manufacturing, Quality Control, Supply Operations, Microbiology and Product teams.
Education and Experience:
- 1 year of Pharmaceutical Industry Quality Assurance experience required
- BS/BA degree in scientific discipline desirable
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 GMP's and their application
- Ability to be gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned
- Experience with Batch Documentation review
- Experience with Visual Inspection and/or AQL Inspection for pharma products
- Experience working in a cleanroom environment
- Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
- Ability to manage multiple responsibilities, fast paced environment with a high degree of self-motivation
- Good written, oral and interpersonal English communication skills
- Ability to use Microsoft Word and Excel applications
- Ability to work a 10-hour shift (includes overtime eligibility)
- Ability to work weekends and holidays
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.
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, move between spaces, and reach with hands and arms. 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 items weighing up to 30 pounds.
Employee is required to work in a cleanroom environment, which requires gowning consisting of coverall, foot and head coverings, facemask, and gloves. Noise level is moderate with consistent equipment operation.
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 $ per hour to $ per hour.This role is classified as non-exempt and eligible for over-time.
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.
The base pay range for this role in California is $21.15 per hour to $29.09 per hour. This role is classified as non-exempt and eligible for over-time.
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.
Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
1+ years
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