Quality Systems Specialist Ii

The Quality Systems Specialist II is a crucial role in conducting all aspects of Quality within KLS’s assigned business project portfolio. He/she is responsible for managing, coordinating, facilitating, and implementing quality standards based on cGMP, ICH, and ISO requirements and guidance across all KLS products. The incumbent in this position adheres to KLS quality governing methods, develops and controls quality procedures, and participates in developing programs for improving product quality. The role will focus on implementation of the Quality Management System and ensuring compliance with KLS policies and procedures and conformance with customer requirements.

Specific Duties and Responsibilities:

· Participate in the development, implementation, management, and integration of a Quality Management System (QMS) for all KLS production activities and products.

· Execute routine Document Control activities per KLS SOPs, QMS, and applicable regulatory requirements.

· Write and revise Quality SOPs, and other related procedures.

· Provide user assistance and conduct employee training on document control and record management systems and procedures.

· Maintain the Training program and deliver employee training on applicable quality SOPs, regulatory requirements, or standards under the guidance of Quality Management.

· Manage and update KLS training matrix to ensure employees are appropriately trained on all applicable documents in a timely manner and follow up on outstanding/overdue training.

· Participate in and support the implementation of the EQMS system.

· Support the KLS audit program conducting internal audits and/or hosting client or 3rd party audits.

· Participate in the initiation, documentation, and management of quality events (e.g.: deviations, CAPA, change control, complaints).

· Assist in root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.

· Collect and analyze Quality performance data, statistically analyze, and report to management on quality issues, trends, and losses.

· Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

· Serve as a trainer for other Quality personnel as needed.

· Provide general support for the overall Quality Management System and perform other related quality duties as assigned or identified.

Requirements:

• Bachelor’s degree in the sciences.
• Experience (3-4 years) working in a GXP or ISO regulated environment.
• Ability to interpret regulatory standards and implement sound risk-based decision making that ensures compliance with applicable governance.
• Experience (1-2 years) in a Quality related role in a controlled work environment.
• Experience with EQMS or EDMS (MasterControl) preferred.
• Experience in executing internal or supplier audits and hosting external audits nice to have.
• ASQ certification such as CQA or CQE is a plus.
• Must have excellent skills in organization, negotiation, 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 50 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 speak and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.

*Employment with Kinovate Life Sciences, Inc. (KLS) is at-will. This means your employment is for an indefinite period of time 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 be 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.

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.