Quality Control Laboratory Specialist III

Job Location: Oceanside, CA

Qualifications:

• Bachelor’s degree in Science or equivalent work experience.
• 5-10 years working in a GXP or ISO regulated environment.
• 2-5 years in a Quality Assurance related role
• Must have excellent skills in organization, negotiation, problem solving and time-management.
• Able to attend to detail and act decisively.
• Must have excellent interpersonal, written, oral presentation and verbal communication skills.
• Proficient in Microsoft Word, PowerPoint, Access and Excel.
• Must be able to travel domestically/internationally (~10%)

Duties & Responsibilities:

• Managing, coordinating, facilitating and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements.
• Reports to the Quality Manager: assists management with the development and implementation of internal controls, standards, processes and procedures for managing the company’s QMS and quality programs.
• Directs quality assurance methods, participates with internal Quality training for all the company employees
• Monitors production conformance with QA standards and procedures
• Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).
• Conduct employee training on applicable Quality SOPs, regulatory requirements and ISO/ICH standards
• Iinitial contact and quality control resource for quality event or nonconformance identification, report write-up and quality event documentation/investigation.
• Proposes appropriate correction, corrective action plans and measures and effectiveness verification for CAPA/Deviation resolution and closure.
• Review/release regulatory document packages (including batch records, CoAs and other related documents) for each product
• Generates/signs/approves applicable records including Certificate of Conformance and/or Certificate of Analysis for product lot/batch releases.
• Perform internal and participate in external customer or notified body quality audits.
• Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program. Maintain ASL as required.
• Prepare audit plans, agenda and final reports based on audit findings as appropriate,
• Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action plan is implemented.

Job Type: Full-time

Salary: $30.00 - $40.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• How many years of experience working in a GXP or ISO regulated environment? How many years of experience in a Quality Assurance related role?
• Are you amenable to work in Oceanside, CA? Do you have working permit?
• Where is your current location?

Work Location: One location

Salary : $30 - $40