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.