Manager, Quality Assurance & Regulatory Compliance
Company: inTulsa
Location: Tulsa
Posted on: April 19, 2024
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Job Description:
*InTulsa is partnering with Botanic Tonics -to -find candidates
for this exciting role in Tulsa*
**Location: Tulsa, OK. - This is an onsite position for those
already in Tulsa, OK or willing to relocate to Tulsa, OK**
At Botanic Tonics, we know our world is fast, noisy and
distracting. It can easily leave us feeling tied up, strung out and
not ourselves. Maybe you think the more supercharged you are, the
better you'll be. Maybe escape is the only way for you to truly
feel free. We're not judging - we just have a different point of
view. Because we're not a fuel for keeping pace with the rat-race
of every day. We're not an elixir that transports you through the
clouds to a tranquil place. We're kava products with blends of
other naturally active ingredients, designed to bring you down to
earth and into the present, so you can make the most of every
moment.
Why waste effort trying to quiet the noise when you can tune into
it, to hear the one voice that matters? We believe choosing to
engage with the here and now is more fulfilling. It makes us feel
good, enriches our lives, and brings out our best selves.
Be Present. Be You. When you can truly be there, you feel free.
As the Manager of Quality Assurance and Regulatory Compliance, you
will play a key role in upholding our company's commitment to
producing safe, effective, and compliant dietary supplements. You
will oversee all aspects of quality assurance, regulatory
compliance, and product safety, ensuring that our products meet or
exceed industry standards and regulatory requirements.
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Responsibilities
Quality Assurance Management
Develop, implement, and maintain comprehensive quality assurance
programs to ensure the safety, purity, and efficacy of all dietary
supplement products.
Establish and enforce quality control standards and procedures
throughout the manufacturing process, from raw material sourcing to
finished product distribution.
Conduct regular audits and inspections of manufacturing facilities,
suppliers, and contract manufacturers to ensure compliance with
company standards and regulatory requirements.
Investigate and resolve quality-related issues, deviations, and
complaints in a timely manner, implementing corrective and
preventive actions as necessary.
Establish and maintain accurate and up-to-date documentation,
records, and SOPs related to quality assurance, regulatory
compliance, and product safety.
Ensure that all required documentation, including batch records,
testing reports, and certificates of analysis, are properly
maintained and accessible for review.
Regulatory Compliance
Stay abreast of current regulations, guidelines, and industry
trends related to dietary supplements, including but not limited to
FDA regulations, DSHEA, cGMPs, and other applicable standards.
Interpret and apply regulatory requirements to product development,
labeling, advertising, and marketing activities, ensuring
compliance with all relevant laws and regulations.
Prepare and submit regulatory filings, notifications, and
documentation to regulatory agencies as required.
Serve as the primary point of contact for regulatory agencies,
auditors, and third-party certification bodies during inspections
and audits.
Supplier and Vendor Management
Evaluate and qualify suppliers and vendors based on their ability
to meet quality, safety, and regulatory requirements.
Conduct supplier audits and assessments to ensure compliance with
company standards and regulatory expectations.
Establish and maintain strong relationships with suppliers and
vendors to facilitate communication and collaboration on quality
and regulatory matters.
Training and Development
Provide training and guidance to staff members on quality assurance
principles, regulatory requirements, and best practices.
Foster a culture of quality and compliance throughout the
organization by promoting awareness and accountability at all
levels.
Qualifications
Bachelor's degree in a relevant scientific discipline (e.g.,
chemistry, biology, food science, pharmacology) required; advanced
degree preferred.
Minimum of 5 years of experience in quality assurance and
regulatory affairs within the food & beverage, dietary supplement,
pharmaceutical, or related industry.
Thorough understanding of FDA regulations, cGMPs, and other
relevant standards for food & beverages and dietary
supplements.
Strong knowledge of quality systems, auditing techniques, and risk
management principles.
Excellent communication, interpersonal, and leadership skills.
Detail-oriented with the ability to prioritize tasks and manage
multiple projects simultaneously.
Certification in quality management (e.g., ASQ Certified Quality
Auditor) or regulatory affairs (e.g., RAPS Regulatory Affairs
Certification) preferred.
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Salary
$110K - 130K annually + 20% bonus
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Botanic Tonics is an equal employment opportunity employer.
Candidates are considered for employment without regard to race,
creed, color, national origin, age, sex, religion, ancestry,
veteran status, marital status, gender identify, sexual
orientation, national origin, liability for military service, or
any other characteristic protected by applicable federal, state, or
local law. If you are interested in learning the status of your
application, please note you will be contacted directly by the
appropriate human resources contact person if you are selected for
further consideration. Botanic Tonics reserves the right to defer
or close a vacancy at any time.
#Li-onsite
Keywords: inTulsa, Fayetteville , Manager, Quality Assurance & Regulatory Compliance, Executive , Tulsa, Arkansas
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