US
In 2010, we started making sun care products to protect ourselves, our families, and our friends from the damaging rays of the sun. Since then, we’ve grown and expanded into hair care and lip care products, and even launched Baby Bum, our rad plant-based baby skin care line. Along the way, we’ve been building an amazing, like-minded global community of friends that encourage us and help us be better. Today, we are looking for a few more talented and passionate people to join our crew – not for the money or the awesome location to live and work, but for the opportunity to change the world a little with us.
Summary:
The Document Control QA Specialist is and individual contributor who organizes, files and controls cGMP documentation in accordance with company standards. This position is a key role to ensure product and quality system documentation meets the defined quality standards and worldwide regulatory requirements. This position also supports all documentation activities for change control, stability, and specification management.
Essential Duties and Responsibilities:
- Manages document change control process ensuring proper document number assignment, timely review and approval, release, and distribution of controlled documents.
- Communicates changes to contract manufacturers.
- Actively monitors stability program with each contract manufacturer.
- Reviews and updates technical packages as changes occur.
- Performs general filing and record keeping for all incoming vendor documents and quality records.
- Supports quality reviews and audits associated with document control procedures.
- Performs other quality related duties as assigned.
Required Skills / Experience / Competencies:
- Bachelor’s degree in science or related field (Biology, Chemistry, Physics, Engineering)
- Minimum 2-5 years’ relevant document control or quality experience in an FDA regulated facility.
- Excellent written and verbal communication skills
- Proficient in Microsoft Word, Excel, PowerPoint
- Strong teamwork skills
- Strong critical thinking and decision-making skills
Preferred Skills / Experience / Competencies:
- Experience in consumer goods, preferably personal care, and OTC’s
- Knowledge pertaining to the regulations related to FDA CFR 21 Part 210/211, Health Canada, TGA, and EU.
- Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
- Experience working with software systems such as Coptis, Airtable and ASANA preferred.
Job Requirements:
- Full Time
- Up to 5% overnight travel
$60,800-$79,800 is the salary range for this position. It represents a portion of the overall compensation package (bonus eligible), and there is flexibility based on the candidate's qualifications.
