Quality Assurance Specialist I

1 day ago


Oceanside, California, United States Kinovate Life Sciences, Inc. Full time
Job Description

The Quality Assurance Specialist I is a critical role in ensuring the quality of products and services at Kinovate Life Sciences, Inc. This position is responsible for implementing and maintaining quality assurance standards based on regulatory requirements, such as cGMP, ICH, and ISO. The ideal candidate will be detail-oriented, have excellent communication skills, and be able to work independently with minimal supervision.

Key Responsibilities:

  • Order fulfillment support, including line clearance, product packing documentation verification, and final label review.
  • Incoming inspection of raw materials and packaging components, issuing controlled QC test records and submitting to QC.
  • Issuing controlled batch record documentation to Production.
  • Reviewing completed raw material documentation, packaging component documentation, finished product batch record documentation, and associated QC test records for compliance against applicable regulations, policies, and standard procedures.
  • Releasing and issuing material and finished products labels for Production use and/or order fulfillment.
  • Assisting with the controlled document change and revision process.
  • Photocopying, scanning, and filing e-documents and hard copy documents.
  • Collating reports and documents for/from Production, QC, and QA.
  • Preparing documents for long-term archival.
  • Creating and updating training folders.
  • Issuing, maintaining, and periodically reviewing equipment logbooks and calibration/qualification records.
  • Assisting in the execution of quality audits under supervision.
  • Assisting with the initiation and documentation of quality events, such as deviations, CAPA, change control, and complaints, under supervision.

Requirements:

  • Bachelor's degree in Science or equivalent work experience.
  • Experience (1-2 years) working in a GXP or ISO regulated environment.
  • 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.
  • 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.

Disclaimer: This job description reflects management's assignment of essential job duties; and nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Disclaimer: Employment with Kinovate Life Sciences, Inc. is at-will. This means your employment is for an indefinite period and it is subject to termination by you or Kinovate Life Sciences, Inc., with or without cause, with or without notice, and at any time. Nothing in the policy or any other policy of Kinovate Life Sciences, Inc. shall be interpreted to in conflict with or to eliminate or modify in any way, the at-will employment status of Kinovate Life Sciences, Inc. employees.

Disclaimer: Kinovate Life Sciences, Inc. prohibits discrimination and harassment based on the following characteristics: race, color, caste, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic conditions), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, age (40 years and over), sexual orientation, veteran or military status, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, and any other characteristic protected by state or federal antidiscrimination law covering employment. These categories are defined according to Government Code section 12920. In addition, Kinovate Life Sciences, Inc. prohibits retaliation against a person who engages in activities protected under this policy. Reporting, or assisting in reporting, suspected violations of this policy and cooperating in investigations or proceedings.

About Kinovate Life Sciences, Inc.

Kinovate Life Sciences, Inc. was established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide. Since its inception, Kinovate has grown to become the market leader in the market for solid supports in the oligonucleotide synthesis field. With a history of success based on outstanding materials, superior service, and competitive costs, Kinovate has established itself as the reliable supplier of choice to oligonucleotide drug development companies, contract manufacturers, oligo houses, and numerous other players in the field. Kinovate boasts unparalleled resources in the areas of R&D, manufacturing, analytical development, Quality Control, technical, and a World Class customer support. Kinovate has built a dedicated and hardworking team with a commitment to continuous improvement, striving to provide the highest quality products at the best prices.



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