Quality Assurance Specialist I

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

Specific Duties and Responsibilities:

· Order fulfillment support to include (but not limited to): Line clearance support for packing activities, product packing documentation verification and review, and final label review.

· 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 issue material and finished products labels 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.

· Creating and updating 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.

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.

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

*KLS 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,1 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, KLS 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.