Clinical laboratory scientist [h1.location_city]

Job Description

Kinovate Life Sciences, Inc. 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 solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer.

Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more.

Production Lab Assistant

Under direct supervision, partner with manufacturing leadership to provide tactical services in the production of commodities for the organization. Partner with a variety of departments across a cross-functional organizational matrix, e.g., Quality Assurance (QA) / Quality Control (QC) and Supply Chain (SC). Work within the Good Manufacturing Practices (GMP) environment and the International Organization of Standardization (ISO) manufacturing environment. Follow Standard Operating Procedures (SOP’s) and policies ensuring the final product is delivered safely and with quality.

ESSENTIAL DUTIES and / or RESPONSIBILITIES :

1. Assists the Production Specialists before and during all manufacturing activities.

2. Reviews production schedule to determine what raw materials to assemble including any consumables for the manufacturing of all products and batches sizes. Ensures pre-production data meet the customer specifications and Quality Assurance (QA) requirement before proceeding to manufacturing batches.

3. Ensures that health and safety guidelines are strictly followed.

4 .Assembles, installs, cleans, operates, and maintains all production equipment.

5 .Cleans the production suits according to the established procedure and fill the corresponding documents.

6. Maintains the equipment helping the teams with storage of supplies inventory.

7. Prepares for production by reviewing production schedule, assisting production personnel by assembling materials and supplies for loaded solid supports.

8. Sustains an inventory of manufacturing materials and consumables required for production.

9. Completes manufacturing documentation according to good manufacturing and documentation practices where applicable.

10. Adheres to SOP’s, batch record, and documentation to support manufacturing processes.

11 .Organizes workstation to prioritize multiple tasks.

12. Other duties as assigned.

MINIMUM EDUCATION and / or EXPERIENCE :

1. High School Diploma or GED certificate and one (1) to three (3) year’s directly related laboratory experience or equivalent combination of education and experience preferred but not required.

2. Experience in 5S and manufacturing and inventory management, a plus.

KNOWLEDGE, SKILLS and / or ABILITIES :

1. Knowledge of pharmaceutical and chemical manufacturing industry concepts, as well as SOPs, including, documenting manufacturing processes consistently and accurately.

2. Ability to work with other departments across the organization to achieve goals.

3. Familiarity with operating production equipment including reactors, stirrer, vacuum pumps, and vacuum ovens and automated manufacturing methods and understanding of workflow processes.

4. Ability to work with a high volume of data with a high-level of accuracy, strong attention to detail and good follow-up and follow-through while doing repetitive tasks.

5. Work independently as well as in a small and / or large group and foster cooperation in a team environment using interpersonal skills to document working knowledge.

6. Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement.

7. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands / pressures in a fast-paced environment.

8. Strong ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills.

9. Basic Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, etc.

10. Ability to read and interpret documents such as SOPs, safety rules, written instructions, checklists, and reports.

11. Good communication skills to write and verbally present in understandable terms and respond to questions from peers and supervisors.

12. Understanding of KLS Quality Management System and EHS policies.

PHYSICAL DEMANDS and / or WORK ENVIRONMENT : (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

1. Sit for 20%-30% of time at a desk doing sedentary reports, research, work with computer and interfacing with others on the manufacturing floor.

2 .Must be able to stand / walk frequently up to 6 hours in a day.

3. Ability to occasionally lift / carry items up to 30 pounds as well as overhead.

4. Ability to push / pull carts or pallet jacks loaded with raw materials, work in progress and finish goods occasionally up to 3 hours in a day.

5. Ability to grasp objects with a force up to 30 pounds.