Q.A. SPECIALIST SR
This position performs as QA analyst in the area of quality assurance oversight of operations, production, process and equipment systems and validations at the Bioscience Laboratories Irvine facility.
This position is responsible for one or more of the following duties or activities:
• Quality Assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
• Serving as the QA representative on validation and technical services projects.
• Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.
• Supporting change control activities associated with processes and equipment validations.
• Managing the review/approval of DS development master batch records, executed batch records, manufacturing data, and validation and technical reports.
• Maintain a clean and organized work area.
• Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
• Perform all assigned duties according to departmental SOP’s and cGMP’s.
• Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
• Complete and remain current with all required cGMP and safety training.
• Perform other duties as assigned.
Education: BS degree in Biology, Chemistry, Biochemistry or a closely related discipline (or equivalent years of experience).
Certification: CQA is preferred
Experience: Technical Minimum of five (5) years of QA experience within a pharmaceutical environment.
QC analytical experience is preferred
Experience: IT Systems Strong user of word processing programs
Experience: Regulatory Prefer experience in a GMP regulated environment
Essential Knowledge, Skills & Abilities:
• The ability to comprehend processes in short time frames, coupled with the need to effectively communicate verbally and in writing.
• Development of problem-solving approaches that can be applied to multiple functions within the DSO organization.
• Proven ability to generate results.
• Ability to be an effective and active teacher and mentor
• Ability to interpret multiple standards and apply to department activities.
• Process and results oriented with the ability to lead cross functional teams and solve key problems
• Strong analytical skills including proficiency in the use of computer applications and office automation
• Excellent interpersonal and verbal/written communication skills
• Desire to take on increased levels of responsibility
• Ability to travel about 5%
|Qualification ||Rating |
|Must Have |
|Education & Experience |
|Will this position require driving? || || |
|Prior experience with Change Controls, CAPA, Non-conformances, and Laboratory Investigations is mandatory. |
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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