Job details

Quality Associate Manager

(External) What You Need:

Bachelor of Science degree in Biology, Chemistry, or related science field
Minimum 2+ years of experience in quality
Minimum 2+ years of leadership experience in quality in a manufacturing environment
Solid knowledge of cGMP, GDP, ISO regulations, guidelines and associated regulatory requirements
Strong written and verbal communication skills, and problem-solving skills
Commitment to model and live out our Core Values (Accountability, Community, Innovation and Courage) and a positive mindset are critical for success and should reflect in everything you do

The salary range for this positoin is between $85,000 - $95,000 plus annual bonus.

Arbonne International is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sexual orientation, national origin/ancestrym agem sexual orientation, gender identity, gender expression, military/veteran status, marital status, disability status or any other basis prohibited by law. At Arbonne International it is about each person bringing passion and skills to adynamic and inclusive workplace!

(External) What You'll Be Doing:

Review and approve incoming raw material and component inspection forms completed by Incoming Inspector, in-process raw material qualification (RMQ) and testing, bulk testing and finished good testing. This includes review and approval of all related documentation such as Finished Good CoA’s and test results, etc.
Have a general understanding of the QC Laboratory, performing pH, viscosity, specific gravity, gluten, color, odor, appearance, and FTIR testing. Assist with creating in-process and finished good CoA’s. Assist with organizing samples and filling out sample submission forms to be sent to third party testing labs, as needed.
Assist with packaging/filling production preparedness, line clearance, and in-line quality checks/inspections and sampling, as needed.
Perform final Batch Record quality review and approval, and product release, as needed.
Ownership of the Discrepancy/Deviation and Out of Specification (OOS) Program. Manage, conduct, and assist with investigations of discrepancies that have been initiated, assess product/material impact, disposition; perform thorough root cause analysis and determine whether Corrective Action Preventive Action (CAPA) is required.
Ownership of the Corrective Action Preventive Action (CAPA) Program. Once root cause has been determined collaborate with various functions/departments to determine actions required. Follow-up and ensure CAPA actions and continuous improvement efforts are on track to implementation and meeting timelines established. Ensure CAPA’s are monitored and closed on time. Ensure effectiveness checks are established and properly outlined, when needed; and monitored.
Ownership of the Change Control Program for product/process changes as well as procedure changes. Assist the Quality Document Specialist leading and managing the change controls has support, and staying on track with upcoming changes. Monitor changes and timelines.
Evaluate current procedures against current processes and practices, and write/update, and/or revise procedures (i.e. – SOP’s and Forms), as needed, to reflect and ensure current practices are captured
Assure regulatory compliance with cGMP and ISO-standards, by quality oversight, conducting periodic internal audits, mock recalls, addressing gaps, and instituting improvements throughout the warehouse and facility.
Oversee the Document Management and Training Program. Ensure the Quality Document Specialist has the tools to properly manage documents. Conduct training with other quality and management counterparts, as needed. Assist with maintenance of training records.
Support management with various inspections by regulatory agencies such as FDA, TGA, Health Canada, and other similar agencies and certifications, (i.e. Gluten certification, etc.) by acting quickly to mitigate potential problems, support timely and accurate transfer of data/documents and information to inspectors/auditors. Assist management with responses and appropriate corrective actions.
Support aspects of new product introductions that will require quality and regulatory assessment and compliance.
Oversee and manage the Stability Program. Write Stability Protocols and ensure results for each timepoint are requested, reviewed, and archived; and stability log is updated and maintained.
Assist in writing OTC batch validation protocols and reports. Review stability and other test results that establish expiration dates or shelf life, and safety and efficacy of new products.
Review and analyze, and help address product quality complaints, trends, and investigations. Write investigation reports, when needed.
Assist with writing and/or reviewing and approving Annual Product Reviews (APR’s) for OTC products.
Assist the Director of Quality with review of Customer Quality Agreements (QAG’s), as needed; and ensure customer requirements are met once manufacturing for the customer begins, as required.
Other relevant duties as assigned.
Each employee is responsible for raising awareness of our commitment to Corporate Social Responsibility and should actively participate in activities and initiatives which are designed to have a positive impact on the environment and local communities.
As an employee of a purpose-driven company, you are required to establish a goal relative to social and environmental impact.

(External) Why You're Here:

The Quality Associate Manager is an intricate and critical member of the manufacturing facility in Chatsworth, CA; ensuring compliance with Good Manufacturing Practices (GMP’s), robust deviation/discrepancy investigation, validation activities for Over the Counter (OTC) products, change controls, Annual Product Reviews (APR’s), and assisting with regulatory inspections.

Arbonne Glassdoor Company Review

3.5

Arbonne DE&I Review

3.7

CEO of Arbonne

Tyler Whitehead

Approve of CEO

By Arbonne

Our mission is to empower people to flourish through healthy, sustainable living. We take a holistic approach, focusing on the whole you — mind, body and skin.

FUNDING

INDUSTRY

TEAM SIZE

LOCATION

Hybrid, based in Irvine, CA

DATE POSTED

April 15, 2023