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1+ months

Operations Manager - Scientific

Kelly Services
Hayward, CA 94540
**Job Title: Operations Manager**


**Work Location:** Hayward, CA.


**Job Description:**


Our Client is an emerging biotechnology focused on biosample collection technologies. Our iSWAB-Microbiome product is a disruptive technology being used in large quantities worldwide for COVID-19 sample collection. We are seeking an experienced Operations Manager to join our team. This is a new position and excellent ground-floor opportunity with significant room for growth and advancement.


The **Operations Manager** will have a proven track record of setting up and running manufacturing and supply chain operations, ISO compliance, procurement, and process automation for high volume manufacturing in a regulated environment. This position reports directly to the CEO and will play a key role in the expansion of our business as we transition into ISO certification and FDA approval. The ideal candidate will be analytical, experienced in collecting, processing and presenting data on production levels, costs and capable of envisioning and justifying new operations. The Operations Manager will be committed to finding ways to improve operations while assuring that all quality requirements are maintained and improved, and will have hands on experience in general operations, facility management and capital projects.


To ensure success, you should have an understanding of the FDA's QSR, ISO 13485 and applicable ISO standards as well as a strong understanding of ERP systems, preferably the Netsuite platform.


Responsibilities:


+ Manage product manufacturing, packaging, labeling, and boxing of all products.

+ Manage inventory levels to assure growth targets can be met.

+ Determine manufacturing equipment requirements; participate in equipment specification, acquisition and qualification.

+ Assure products meet quality requirements and are manufactured per applicable standards.

+ Implement and maintain ISO and /or other registrations as appropriate.

+ Working with QA, RA, and production staff to implement ongoing cost savings and quality improvements. Modeling workflow, analyzing potential automation alternatives. Evaluating potential improvements to manufacturing workflow to improve output, efficiency, lower cost and improve quality.

+ Setting production schedules, material and manpower resources to meet output objectives.

+ Maintain a variety of reports, records and production documentation to reflect schedules, performance, methods and the like.

+ Assure, together with quality and leadership teams, manufacturing compliance with GMP, ISO 13485.

+ Create, execute and complete validation and qualification (IQ/OQ/PQ) documents.

+ Support of the product and process development for new products, product changes and enhancements.

+ Parts receiving including incoming inspection and managing the warehouse.

+ Support equipment maintenance and support equipment service needs.

+ Establish process controls, statistical measures of manufacturing performance and quality.

+ Establish manufacturing objectives and metrics.


Requirements:


+ You should have at least five years of relevant experience and training in manufacturing, and or operations with excellent communication skills and ability to build cross functional teams.

+ Bachelors degree in business, accounting, engineering, or a related field

+ Minimum of 5 years of experience in medical device or other regulated manufacturing environment.

+ Previous P&L responsibility preferred

+ Relevant experience scaling to high volume production of medical products

+ Familiarity with FDA QSR and ISO 13485 medical device regulations.

+ Ability to deliver under tight deadlines with a focus on quality.

+ Led successful manufacturing operations preferably with ISO 13485 control requirements.

+ Strong oral and written communication and presentation skills. Effective communicator of technical & non-technical information.

+ Experience with managing processes and documents for GMP, ex: IQ/OQ/PQ.

+ Authorized to work in the United States on a full-time basis, full fluency (verbal and written) of the English language is a must.

+ Working knowledge of PC applications software and manufacturing systems software.

+ Must have the mindset and ability to thrive in an entrepreneurial early stage company environment. Someone who is resourceful and can work independently. Can effectively make optimal use of limited resources and has an ability to work closely with others in a small team setting.


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-08 Expires: 2021-04-29

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Operations Manager - Scientific

Kelly Services
Hayward, CA 94540

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