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QA and R & D Manager, Chicago Area % – OPUS International

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Our consumer is a rising biosciences firm that manufactures and markets science-based, top-quality pure dietary supplements, complement blends, and nootropics to assist the physique and thoughts

Since its inception in early 2010, the corporate has earned the belief of a rising set of “within the know” clients via product innovation, uncompromising high quality, and distinctive customer support.  In more moderen years, the administration broadened the corporate’s scope and the vary of merchandise to succeed in a wider addressable market within the self-care and wellness house. Their model not too long ago launched new merchandise in varied codecs (pure powders and stacks, formatted as bulk powders, capsules, liquid blends, and future gummy manufacturing) and reworked its web site to succeed in this broader target market.

Additionally, to accommodate its progress plans, the corporate bought and relocated to a brand new manufacturing facility situated in a nice company park surroundings in Illinois.

Their Mission

Their mission is to enhance the standard of your life.

They imagine wellness shouldn’t be reserved for the rich or these with specialist data. They imagine that everybody has the precise to really feel their finest, and it’s their mission to make it simple.

Their Values

Their Values are easy: Buyer Focus, Teamwork, Pushing the Boundaries.

They differentiate themselves with New Product Innovation, Distinctive Buyer Service, and by by no means compromising on High quality.

The corporate is at the moment looking for an R&D and QA Supervisor.

Reporting on to the Founder & the Chief Science Officer, the R&D & QA Supervisor will lead all features of product growth from idea to commercialization in addition to be answerable for constructing and managing the High quality Administration System. Reporting to the place are one PhD product Developer and three QA technicians.

Who You Are And What You’ll Do

The QA and R&D Supervisor will handle all features of the New Product Improvement & High quality Assurance Program. This particular person can be answerable for constructing and managing the High quality Administration System and creating the workforce’s in-depth data of the regulatory necessities established by FDA GMP as relevant to dietary dietary supplements. As our consumer is a small firm, this particular person can be anticipated to spend time on the manufacturing line to troubleshoot high quality points or attend to start-up for brand new product trials, and so forth. The person should have glorious management, communication, and interpersonal abilities to work inside a fast-paced workforce surroundings that requires the power to deal with a number of calls for. The incumbent will work very intently with each the CSO (Chief Science Officer) and CMO (Chief Advertising Officer) with a robust emphasis on technical documentation, communication, and coordination to roll out new merchandise. The incumbent can even work intently with the COO and Operations to make sure compliance with all relevant components of the FDA GMP laws and product specs.

This Consists of:

Map out a technical growth plan and supervise the formulation and growth course of for brand new merchandise.
Overview and approve all Product specs, Course of CCPs, and Product Labels.
Help administration of present and new supplies suppliers via actions that guarantee high quality/identification and purity, in addition to compliance with relevant regulatory necessities.
Facilitate the institution and upkeep of an appropriate doc administration system for compliance with FDA GMP necessities.
Present periodic regulatory coaching.
Lead inner audits and subsequent applications to make sure GMP compliance and procedures are adopted all through the location.
Characterize the Firm throughout FDA inspections.
Direct and facilitate investigations for deviations as wanted, and lead CAPA.
Set up applicable high quality metrics per enterprise goals, and periodically report progress.
Overview and approve or reject all completed items, procedures, specs, supplies, and protocols.

What You’ll Want To Succeed

This can be a hands-on place in a dynamic surroundings, which remains to be constructing essential capabilities whereas creating platform innovation. A powerful technical background in addition to management and flexibility are essential for fulfillment:

A Ph.D., M.S., or B.S. in Chemistry, Biology, Engineering, or associated area.
A working data of latest product growth and processing in meals, pharma, or associated section in CPG trade.
5+ years of management expertise in Regulatory Affairs, Pharmaceutical High quality Administration, or associated area.
Robust working data of FDA CGMP and pointers.
Wonderful communication and interpersonal abilities to work inside a various and quickly altering work surroundings, speaking with senior managers and colleagues to make sure efficient implementation and compliance of the standard program.
A confirmed monitor document of creating, implementing, main, and managing a CGMP-compliant high quality program is crucial.

Advantages:Our consumer gives aggressive compensation and advantages together with medical, dental, imaginative and prescient, life insurance coverage, trip, 401(okay), and paid holidays.

401(okay) matching
Dental insurance coverage
Versatile schedule
Medical insurance
Well being financial savings account
Life insurance coverage
Paid time without work
Imaginative and prescient insurance coverage

Our consumer is dedicated to range and inclusion to drive enterprise outcomes and create a greater future each day for his or her various workers, world customers, companions, and communities. They imagine a various workforce permits them to match their progress ambitions and drive inclusion throughout the enterprise. All certified candidates will obtain consideration for employment with out regard to race, shade, faith, intercourse, sexual orientation, gender identification, age, nationwide origin, or protected veteran standing and won’t be discriminated in opposition to on the idea of incapacity.

Employment is topic to verification of pre-screening checks, which can embrace background verify, credit score verify, and DMV verify.

 

All Candidates should be capable to work within the U.S. with out sponsorship.

For extra data, please contact Moira McGrath at  OPUS Worldwide, Inc. at (954) 428-3888 or [email protected]

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