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Quality Assurance Specialist

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.

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring compliance with all necessary regulations. This will include maintaining and controlling documentation (SOPs, WIs), assigning document generation to necessary personnel, and reviewing and signing off on all documentation.

Key Responsibilities

  • Preparing, submitting for approval and implementing (if necessary) quality assurance policies and procedures.

  • Documenting QA activities and creating audit reports. 

  • Auditing production, R&D and QC records for compliance.

  • Writing and/or revising new and current SOP’s, GMP’s , product specifications and etc.

  • Supporting customer and regulatory audits.   Responding to any observations.

  • Reviewing and completion of  all GMP documentation, including batch records, SOP’s, spec sheets, protocols and reports.

  • As requested, take product samples for submission.

  • Daily review and completion of QA/QC paperwork, to include product testing records.

  • Work as QC Technician, when assigned, when coverage is needed or as backup when requested.

  • Organize and maintain product retain storage room.

  • Print labels for QC when needed.

Required Skills/Abilities:

  • Understanding of FDA dietary supplement regulations and labeling policies

  • Demonstrated ability to communicate across all levels of the organization; must be able to clearly articulate technical information to a non-technical audience both verbally and in writing

  • Ability to build professional relationships with cross functional teams while facilitating a collaborative environment both internally and externally

  • Excellent communication skills are required (written and verbal)

  • Ability to organize, multitask, and work in a fast-paced environment.

  • Strong technical writing skills with proficiency in Microsoft Suite.

Education and Experience:

  • Preferred:  Degree in Science related field or equivalent experience.

  • Minimum of 2 years in QA position

  • Experience in GMP manufacturing, QA/QC

  • Experience with 21 CFR 111, ICH Q7

  • Ability and experience working with regulatory agency

 

Physical Requirements:

  • Prolonged periods sitting at a desk and working on a computer.

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.

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Average salary estimate

$60000 / YEARLY (est.)
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$50000K
$70000K

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What You Should Know About Quality Assurance Specialist, Botanic Tonics

At Botanic Tonics, we believe in the power of presence and authenticity, and we’re inviting a dedicated Quality Assurance Specialist to join our vibrant team in Tulsa. In this role, you’ll take charge of ensuring that our products meet all necessary regulations and quality standards while embodying our philosophy of bringing people down to earth. Your responsibilities will include preparing and implementing quality assurance policies, maintaining critical documentation, and conducting audits across production and R&D channels. You’ll collaborate with various teams to facilitate a cohesive work environment, guiding them through the intricacies of quality compliance. Whether it’s drafting SOPs, responding to regulatory audits, or assisting in product testing, your attention to detail and technical writing skills will be key. We’re looking for someone who communicates seamlessly across levels, shares our commitment to quality, and thrives in a fast-paced atmosphere. If you have a background in science or a related field, along with experience in QA positions within GMP manufacturing environments, you’ll find yourself not just fulfilling a role but aligning with a movement that promotes holistic well-being. At Botanic Tonics, we celebrate the unique contributions of each team member, and as part of our family, you’ll help us foster an environment where we can all be ourselves and feel free. Come help us on our mission to enrich lives and support a mindful approach to everyday living.

Frequently Asked Questions (FAQs) for Quality Assurance Specialist Role at Botanic Tonics
What are the key responsibilities of a Quality Assurance Specialist at Botanic Tonics?

As a Quality Assurance Specialist at Botanic Tonics, your key responsibilities will involve preparing and implementing quality assurance policies, documenting QA activities, conducting audits, and ensuring compliance with all regulations. Additionally, you'll review GMP documentation, assist in product testing, and maintain quality standards across all functions.

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What qualifications are necessary for a Quality Assurance Specialist position at Botanic Tonics?

To qualify for the Quality Assurance Specialist role at Botanic Tonics, candidates should ideally have a degree in a science-related field or equivalent experience, along with a minimum of two years in a QA position. Experience with GMP manufacturing and knowledge of FDA dietary supplement regulations is also essential.

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How does Botanic Tonics ensure compliance in its quality assurance processes?

Botanic Tonics ensures compliance in its quality assurance processes through meticulous documentation, preparing quality assurance policies, conducting thorough audits, and actively engaging with regulatory agencies. The Quality Assurance Specialist plays a pivotal role in evaluating and signing off on all documentation.

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What skills are important for a Quality Assurance Specialist at Botanic Tonics?

Important skills for a Quality Assurance Specialist at Botanic Tonics include excellent communication both verbally and in writing, strong technical writing abilities, proficiency with Microsoft Suite, and the capability to organize and multitask effectively in a fast-paced environment.

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What kind of work environment can a Quality Assurance Specialist expect at Botanic Tonics?

At Botanic Tonics, a Quality Assurance Specialist can expect a collaborative and engaging work environment that promotes open communication and teamwork. Employees are encouraged to share ideas and contribute to the mission of enriching lives through mindful and high-quality products.

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Common Interview Questions for Quality Assurance Specialist
Can you describe your experience with quality assurance in the dietary supplement industry?

When answering this question, highlight specific positions you've held that are relevant, the types of audits you've conducted, and any regulations you've worked with, especially those related to dietary supplements. Be specific about your role in ensuring compliance and maintaining quality.

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How do you approach writing and revising Standard Operating Procedures (SOPs)?

Explain your process for writing SOPs, including understanding the purpose they serve, collaboration with relevant teams, and ensuring clarity and compliance with industry regulations. Providing examples of past SOPs you've developed can demonstrate your practical experience.

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What steps do you take when faced with a compliance issue during an audit?

Outline your systematic approach, emphasizing the importance of documenting findings, identifying root causes, collaborating with teams to resolve issues, and ensuring timely follow-up actions. Discuss how you communicate these issues to relevant stakeholders.

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How do you prioritize tasks in a fast-paced quality assurance environment?

Share your strategies for prioritization, such as using task management tools, creating to-do lists, and constantly evaluating deadlines. Illustrate this with specific examples where you successfully managed multiple responsibilities.

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Describe your experience working with regulatory agencies.

Discuss any direct interactions you've had with regulatory agencies, focusing on your ability to respond to observations, participate in audits, and stay informed on the latest regulations affecting QA practices in the dietary supplement space.

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How do you ensure effective communication across departments?

Communicating effectively across departments requires building relationships, using clear and concise language, and being open to feedback. Give an example of how you facilitated cross-functional communication in your previous roles.

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What is your experience with Good Manufacturing Practices (GMP)?

In your response, explain your understanding of GMP, your experience implementing GMP in past roles, and how you ensure that your practices comply with these important regulations to maintain product quality and safety.

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Can you provide an example of a time you identified a potential quality issue?

Share a specific story about a quality issue you recognized, your thought process in addressing it, the steps you took to investigate, and how you resolved it to prevent future occurrences, emphasizing your proactive quality assurance approach.

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What tools or software are you familiar with for managing QA documentation?

Discuss any tools you've used, such as document management systems or quality assurance software. Mention your comfort level with Microsoft Suite and other relevant programs that help streamline QA processes.

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Why do you want to work as a Quality Assurance Specialist at Botanic Tonics?

When answering this question, reflect on your personal values and professional goals, emphasizing how they align with the philosophy of Botanic Tonics. Share your enthusiasm for being part of a team that promotes health and mindfulness.

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Full-time, on-site
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December 6, 2024

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