Quality Assurance Specialist
Lincoln Group Industrial Services has partnered with an exceptional client in the Biopharma industry that is looking for a Quality Assurance Specialist to provide financial analysis and reporting that will enable the company and stakeholders to achieve their business objectives. The position will be located on-site in Camarillo, CA.
Shift: 1st shift, 8:00am-5:00 pm
Compensation: Salary up to $70k
Contract: Direct Hire
·Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.
·Regulatory submissions and compliance with applicable national and international regulations.
·Conducts audits and reviews/analyzes data and documentation. Manage internal audit program and support QMS related activities.
·Host customer audits.
·Perform supplier audits, support supplier audit program.
·Initiate, investigate and complete corrective actions (CA). Participate in the MRB meetings. Includes ability to apply problem solving tools and methods to coordinate and/or lead investigation teams.
·Participate in the management and execution of equipment, process and software validation.
·Manage the equipment calibration and maintenance program.
·Provide directions for all aspects of testing related to manufacturing.
oFirst article inspections
oIn-process release inspection.
oFinal QC release of finished goods.
·Ensures that all inspections and procedures are properly completed and documented.
·Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
·Perform environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.
·Assists department with continuous improvements initiatives or lean projects.
·Can serve as Quality Assurance representative on facility projects.
·Respond to customer complaints and collaborate with internal departments for resolution and preventative corrective actions.
·Qualifications: 5-8 years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.
·Strong understanding of global pharmaceutical and biotechnology product regulations with proven experience with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
·Minimum of 5-8 years’ experience with technical documentation for complex activities. This experience should be in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
·Excellent interpersonal and customer service skills required
·Familiar with a variety of the field's concepts, practices, and procedures as SPC analysis. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
·Solid organizational and planning skills required.
·Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
·Must be able to work effectively and efficiently in a team environment.
·Proficient problem solving through the use of continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.
·Demonstrate proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management.
·Good general mathematical skills.
·General computer skills, ERP system as SyteLine, SAP, Oracle, etc.
Requires valid CA driver’s license and proof of valid automobile insurance
About Lincoln Group Industrial Services:
We are a woman-owned staffing firm specializing in Engineering and Light Industrial. We provide you with resources directly to achieve confidence in your workplace. We serve companies looking for a holistic talent solution. First our website at www.lincolngrp.com