QA Associate 1 Job at Pacira BioSciences, Inc.

Pacira BioSciences, Inc. San Diego, CA 92121

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.

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)
  • Assists in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them
  • Facilitates internal training on quality assurance requirements, processes, and procedures
  • Represent QA during production activities
  • Provide floor support for GMP activities
  • Monitor for GMP compliance of all in-process activities during GMP processing.
  • Perform AQL particle inspection of in-process product vials prior to packaging.
  • Able to be gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
  • 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.
  • Ability to search, document and generate quality event reports for Batch Release.
  • Processing of QA Holds with management supervision
  • Maintain databases as required
  • Other duties as assigned

Interaction:

Continuously interacts with other members of the Manufacturing, Quality Control, Supply Operations, Microbiology and Product teams.

Education and Experience:

  • Minimum 1 year of relevant Pharmaceutical Industry Quality Assurance experience preferred
  • BS/BA degree in scientific discipline from an accredited college or university or equivalent work experience


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
:

  • Knowledge of GMP’s and their application
  • Prior experience with Batch Documentation review
  • Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
  • Ability to manage multiple responsibilities with a high degree of self motivation
  • Good written, oral and interpersonal English communication skills
  • Ability to use Microsoft Word and Excel applications


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.


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.




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