QA Associate 1 - Lot Disposition

At Pacira, innovation meets purpose.

Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you.

Why Join Us?

At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.

Purpose:

This person provides hands on quality assurance support to manufacturing operations with a primary focus on batch record review and lot release activities. This role supports the organization's commitment to GMP compliance by monitoring manufacturing activities, reviewing executed batch documentation, and ensuring conformance to established quality systems, procedures, and regulatory requirements. The QA I Associate works closely with cross-functional teams to identify and address quality risks while maintaining real-time floor presence to support compliant operations.

Responsibilities:

1. Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP).
2. Assist in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them.
3. Facilitate internal training on quality assurance requirements, processes, and procedures.
4. Monitor for GMP compliance of all in-process activities during GMP processing.
5. Perform AQL particle inspection of in-process product vials prior to packaging.
6. Perform review of executed Batch Documentation and prepare for disposition.
7. Perform all process steps for the Transfer and Shipment of Batch Records with management oversight.
8. Search and document quality event reports for Batch Release.
9. Maintain databases as required.
10. 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 industry experience in the pharmaceutical or a closely related industry preferred
• 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.

This job requires weekend, holiday and off shift work hours.

Knowledge, Skills, and Abilities:

1. Strong knowledge of GMP's and their application
2. Prior experience with Batch Documentation review
3. Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
4. Ability to manage multiple responsibilities with a high degree of self motivation
5. Good written, oral and interpersonal communication skills
6. Ability to use Microsoft Word and Excel applications
7. Experience with Batch Record Review
8. Experience with Visual Inspection and/or AQL Inspection
9. Experience with working in a cleanroom environment

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. This position requires the individual to pass the AQL particle inspection test of in process product vials.

• 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 is $23.00 per hour. to $30.00 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.