Specialist, Supplier Quality

You’ll be part of the Quality Improvement Engine, a team that is responsible for setting up for success a new state-of-the-art automated packaging, labeling, and fulfillment operation and retail channel.  You will be leading pre- and post- physical product development activities in addition to being the lead investigator for all external investigations.

• Perform and maintain qualification of CMs, Co-Packers, Warehouses, Labeling/Packaging Vendors, Laboratories, including but not limited to regulatory due diligence, audit questionnaire, SOP review, GMP audit, and documentation of all of the above.
• Assume Quality partner responsibilities for Supplier Quality, including Supplier Corrective Action Request (SCAR) and external change control
• Perform root cause analysis for all issues that implicate the product design or are caused by a supplier issue, including complaints, non-conformances (unplanned and planned deviations), OOS (phases 1 and 2), and CAPA investigations.
• Assess and determine critical quality actions (material review, risk, recalls, inspections, etc)
• Determine and create CAPA Action Plans based on root cause
• Author Change Requests for Design Quality to execute on
• Manage release of all retail product including qualification testing, CoA review, and notifications to external partners
• Build and establish a post-market surveillance program for monitoring the performance of physical product

We are encouraging employees (whose job responsibilities allow) to work remotely with the option of returning to the office. We are committed to prioritizing workspace flexibility by building systems to create an inclusive and productive environment in which employees feel most comfortable working (role permitting). 

You will be expected to spend your time working in Brooklyn, NY at least 1-2 days/week, with the option to work remotely the remainder of the time.

You are somebody that is excited by an agile production environment, where change plays a major role, who is ready to take initiative and manage multiple responsibilities within a variety of assigned timelines. You thrive when challenged and are skilled in navigating ambiguity with minimal day-to-day management. You’re ready to roll up your sleeves because you are highly proactive, self-motivated,  highly attentive to details, and have strong organizational and time management skills.

• Minimum Bachelor’s degree in the sciences, engineering, or related field with excellent oral and written communication skills
• Minimum 3-4 years work experience in FDA or ISO9001 (or related) regulated industry
• Strong working knowledge of GxP/GMP compliance and product compliance to FDA’s Dietary Supplement Health and Education Act (DSHEA) and United States Pharmacopeial Convention (USP)

Extra carrots 🥕 (preferred, but not required):

• Experience working in an FDA-registered Food Facility with deep knowledge of Dietary Supplements and Human Foods regulations (21 CFR Parts 111 and 117)
• Experience with technical writing in a regulated environment  is highly preferred
• Experience with electronic Quality Management System (eQMS) (e.g., Master Control, TrackWise, Veeva, Qualityze, etc.)

Even if you don’t meet all the requirements, we still encourage you to apply! If you’re submitting a cover letter, please note what makes you perfect for this role with the qualifications you have.

NYC Metro-Area Salary Range: $80,000-85,000*

Role Level: 2

Your compensation for this role will be based on how your experience aligns with our internal role-leveling, and our internal pay equity standards.

You will be eligible to participate in our Annual Incentive Plan (AIP) which is a cash bonus. Our AIP rewards the achievement of both annual company and annual individual performance objectives. Each employee’s target opportunity for an annual incentive award is a percentage of base salary and varies per role level.

*We have a location based compensation structure; there may be a different range for candidates in other locations.

• Competitive salary + compensation package 
• Competitive insurance packages with free medical, dental, vision plans.
• Unlimited vacation time because you deserve it.
• Free vitamins and powders 
• Wellness perks with free access to online meditation services + fitness reimbursements (at-home workouts count!)
• Virtual team-building events because we value staying connected and building community.
• Socially and culturally relevant experiences geared towards personal + professional learning & development. 
• Working with an amazing, fun-loving, spirited group of people.

Be Humble: Engage in debate with an open mind. Embrace feedback and being wrong when presented with data that shows there is a better option. 

Be Honest: Deliver the truth with humor and love; Recognize and stand up against discrimination on any basis, including race, sex, gender, sexual orientation, religious background, age, or mental and physical abilities - in our work and beyond.

Be Thoughtful: Attack hard problems with thoughtful tenacity. Don’t shy away from complex problems with complex solutions.  

Be Different: Kill your darlings. Don’t be afraid to rewrite something once effective, loved, or widely accepted in the past. Evolution is wonderful. Push against banality and the status quo.

At Care/of, we’re committed to building the best team we can. We hire for potential and support every team member through each step of their career development. Building a diverse, equitable, and inclusive space for our team to think differently and push the status quo is incredibly important to us; and we strive to use these guiding principles as the foundation for how we interact with each other, how we build our business, and how we hold ourselves accountable to our core values. 

Care/of does not discriminate and will not make any hiring decisions based on your race, color, religion, gender identity or expression, sexual orientation, national origin, age, military service eligibility, veteran status, marital status, disability, or any other protected class. If you have a disability and require accommodation during our interview process, please let us know how we can help make the interview process fair to your needs.

IMPORTANT NOTE FOR POTENTIAL CANDIDATES:

On September 9, 2021, President Biden announced a six point COVID-19 action plan. As follow up to the initial announcement, we have decided our policy is to require all Care/of employees to be fully vaccinated by December 8, 2021. This requirement applies to all current and future Care/of employees. Care/of is an Equal Opportunity Employer and it is our policy to provide reasonable accommodations to any qualified individual who because of a medical condition or sincerely held religious belief or practice receives an exemption from the vaccination requirement, provided that such accommodation would not result in an undue hardship for the company.

We know your privacy is important to you. If you'd like to read more on how we protect your information, you can learn more here.