QA Technician, Batch Record Review & Release

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 role is responsible for the thorough review and approval of batch records, ensuring that all necessary documentation and testing have been completed in compliance with company standards and regulatory guidelines. This role is pivotal in ensuring the timely release of high-quality, compliant products to meet production schedules.

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.

* Review batch production records for accuracy, completeness, and compliance with internal and regulatory requirements, including GMP, ISO 13485, and FDA regulations.
* Identify and resolve any discrepancies or missing information in batch records prior to final approval.
* Coordinate with production, quality control, and other departments to address batch record discrepancies or corrections.
* Maintain organized records of batch release activities, ensuring traceability and regulatory compliance.
* Record review: confirm documents, prints, labels, and router accuracy prior to shipping
* Ensure the timely release of product batches in alignment with production schedules and quality standards.
* Communicate quality-related issues or process improvements to management.
* Support incoming control, receiving inspection and raw material release activities when necessary.
* Support internal and external audits by providing quick, accurate access to documentation.
* Execute additional tasks as needed to support the overall QA/QC function and support iovera's operations.
* Maintain high attention to detail, accuracy, and overall quality of work
* Train other employees on responsibilities when necessary.

Supervisory Responsibilities:
This role does not have supervisory responsibilities.

Interaction:
The incumbent works closely with various departments (e.g., QC, QA, Operations, regulatory and within R&D).

Education and Experience:
* Education: High school diploma or equivalent is required
* Experience: Minimum 2 years of experience in a quality control role required, preferably in the medical device, pharmaceutical, or healthcare industry

Knowledge, Skills, and Abilities:

* Knowledge of Good Manufacturing Practices (GMP), ISO 13485, and FDA regulations relevant to medical devices
* Excellent attention to detail and strong organizational skills
* Effective communication and teamwork abilities
* Relevant certifications in quality control, such as CQIA (Certified Quality Improvement Associate), are a plus
* Ability to collaborate across multiple departments

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties of this job include standing, walkingand sitting for extended periods of time. Duties also involve daily keyboard data entry. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse is required. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting with a laboratory, offices, warehouse, and cubicles. Noise level is moderate with consistent printer, telephone ringing and conversation.
Standard business hours, with the possibility of occasional overtime depending on production schedules.

• 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

Pay Transparency

The base pay range for this role in California is $28.00/hr to $39.00/hr. 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