Quality Assurance (QA) Specialist I in Camarillo, CA 

 

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

 

The Quality Assurance (QA) Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations. This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that:

Adherence to cGMPs and internal procedures/policies are maintained Appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. 

 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 

 

We proudly offer

Generous benefit options (eligible first day of employment)  Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities  Education reimbursement 401k program Learning platform And more! 

 

Responsibilities 

Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented Solicit feedback from various departments for operational improvement Author or revise SOPs Review and approve CAPAs, Deviations, Change Controls, Equipment Excursion Reports Assist in performing investigations Perform and/or assist with internal audits and weekly walkthroughs Perform QA visual inspection activities associated with clinical and commercial drug product With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues Assist in developing and delivering training Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs Develop and/or maintain Quality System metrics for management review

 

 

Required Qualifications 

Bachelor’s degree or higher in a relevant field

 

Preferred Qualifications 

Bachelor’s degree in Life Science or related field Experience in a cGMP and FDA-regulated industry Gowning qualification (may be required)

 

Knowledge, skills and abilities

Excellent verbal and written communication skills Focused self-starter with attention to details; team-oriented but able to work independently and proactively, and ability to multi-task Strong problem solving and organizational skills

 

Supervisory Responsibilities

This position does not have supervisory responsibilities.

 

Pay Range: $56,000 - $69,400

 

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

 

 

Physical Requirements

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.

 

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

 

Work Environment

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

 

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

 

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

 

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

 

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.