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Quality Assurance Specialist I - Entry level

Oceanside, CA 92058

Posted: 01/16/2023 Employment Type: Direct Placement Category: Quality Job Number: 95937

Job Description

Position Title: Quality Assurance Specialist I
Reporting To: QA Assistant Manager

Basic Objective:
The Quality Assurance Specialist I is a crucial role in conducting all aspects of Quality Assurance within our assigned business project portfolio. He/she is responsible for facilitating and implementing quality assurance standards based on cGMP, ICH and ISO requirements across all our products. The incumbent in this position is detail oriented, adept at data entry, has good communication skills and possesses the ability to follow directions exactly as given and be capable of working with limited supervision. Ability to write and review SOP and reports is highly desirable.

Specific Duties and Responsibilities:
  • Order fulfillment processing to include (but not limited to): shipping document preparation, packing and shipping orders, weighing product, issuing product label(s), preparing final packaging, arranging for shipments and notifying customers of order fulfillment.
  • Incoming inspection of raw materials and packaging components. Issue applicable controlled QC test records and submit to QC.
  • Issue controlled batch record documentation to Production.
  • Review completed raw material documentation, packaging component documentation, finished product batch record documentation and associated QC test records for compliance against applicable regulations, policies, and current standard procedures.
  • Release and label materials and finished products for Production use and/or order fulfillment.
  • Assist with the controlled document change and revision process.
  • Photocopy, scan and file e-documents and hard copy documents.
  • Collate reports and documents for/from Production, QC and QA.
  • Preparing documents for long term archival.
  • Create and update training folders.
  • Issue, maintain and periodically review equipment logbooks and calibration/qualification records.
  • Under supervision, assist in the execution of quality audits.
  • Under supervision, assist with the initiation and documentation of quality events (e.g.: deviations, CAPA, change control, complaints).
  • Other duties as assigned or identified.

Requirements:
  • Bachelor’s degree in Science or equivalent work experience.
  • Experience (1-2 years) working in a GXP or ISO regulated environment.
  • Must have excellent skills in organization, problem solving and time-management.
  • Able to attend to detail and act decisively.
  • Ability to work under pressure, manage several tasks at once and meet tight deadlines.
  • Must have excellent interpersonal, written, oral presentation and verbal communication skills.
  • Proficient in Microsoft Word, PowerPoint, Access and Excel.

Physical Job Requirements:
Office/Lab environment. Lifting up to 20 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, as well as reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.

Compensation
  • $20 to $24 Hourly
Benefits Offered
  • 401K, Dental, Life, Medical, Vision
Employment Type
  • Full-Time

P-OCE-3
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