The Clorox Company Corporate Quality Specialist in Durham, North Carolina
Make your mark
At Clorox, we build big brands that make everyday life better, every day. We value our differences, and challenge each other to think and act boldly. We try new things, succeed, fail and keep learning. We work hard, and have busy personal lives. And we’re all able to make a positive impact – at Clorox, in our communities, and in the lives of millions of people who invite us into their homes. Make your mark and help us drive Good Growth – growth that is profitable, sustainable and responsible.
The Corporate Quality Specialist in this position will manage the Annual Product Stability and the Corrective and Preventive Actions (CAPA) process, External Manufacturer (co-packer) release, internal auditing program, annual product review, electronic quality management system Intelex and the analysis/review of the data that stems from each of these programs, as necessary. The responsibilities of this role include, but are not limited to, annual stability monitoring, the review, investigation, closure, reporting, analysis, and trending of all complaints and CAPAs related to Burt’s Bees cosmetic and drug products, the overall coordination of annual product /management reviews, review and approval for product lot release, the scheduling/facilitating internal audits and Intelex eQMS support. The Corporate Quality Specialist in this position will serve as the Subject Matter Expert (SME) within the Burt Bee’s business unit for each of these functions.
Manage third party lab product stability reporting to support the overall maintenance of testing results and log review. Coordinate Annual Stability Program with external manufacturers while concurrently monitoring the ongoing product testing requirements to include previous year(s) stability programs each year.
Manage external manufacturer product release. Review production records and quality system documentation to support the release of finished goods.
Manage Internal Audits. Schedule quarterly internal systems/processes and internal content management audits. Coordinate and assist with the conduct of audits according to governing procedure. Document all findings and implement corrective actions associated with findings in anticipation of regulatory audits. Assist with regulatory audits.
Work closely with Complaint Coordinator and assist with customer/consumer complaints and adverse events. Review files to determine the need for investigations. Assign resulting investigations to plant or external manufacturer quality representatives monthly. Review, disposition and close complete investigations. Maintain and continuously improve the procedures utilized to effectively manage the BBI Corporate complaint system all while utilizing the Intelex eQMS platform. Maintain knowledge of industry best practices in terms of complaint handling, quality metrics, and quality data systems. Influence, train and coach BBI & Clorox personnel in complaint system.
Perform review and/or statistical analysis of complaint data, non-conformance deviations, risk analysis, CAPAs, etc. to identify trends and generate monthly, quarterly and ad hoc reports for management review. Assign investigations resulting from the analysis/review as appropriate. Provide metrics and fulfill data requests, as required.
Oversee the organization and coordination of Annual Product Reviews (APR); review and analyze product complaint data, investigations, deviations, nonconformance etc. received from external manufacturers required to complete the annual product review and assessment, generate APR Summary Reports, and facilitate management review.
Issue and log non-conformance and risk estimate numbers as appropriate and complete NCR deviations and REs when necessary. Ensure deviations and risk estimates are processed in a uniform, compliant and timely manner. Assign CAPAs resulting from analysis as appropriate. Manage CAPA Process. Initiate CAPAs when dispositioned investigations, deviations, non-conformances, audit findings, etc. result in the need for a CAPA. Complete CAPAs and serve on project teams when necessary. Review and close complete CAPAs. Ensure CAPAs are processed in a uniform, compliant and timely manner. Maintain and continuously improve the procedures and forms utilized to effectively run BBI Corporate CAPA system while working with eQMS CAPA/Complaints Process Owner. Maintain knowledge of industry best practices in terms of CAPA management, quality metrics, and quality data systems. Influence, train and coach BBI & Clorox personnel in CAPA system.
Perform other duties as assigned, including but not limited to, assisting with the management and support of the Burt’s Bees Corporate Document Control within Intelex as needed.
Key Skills, Abilities and Experience Required
Bachelor’s degree from an accredited institution is requires (Natural Sciences, Engineering or Physical Sciences is desired)
6 years of experience in product manufacturing environment (HIGHLY prefer personal care)
Knowledge of cGMP and FDA regulations, Drugs/OTC, Cosmetic and Personal Care Products, Product Stability
3 years related work experience within Quality Compliance or within a Regulated Business that includes experience in statistical analysis/ data review or data management, execution, and program/process evaluation.
Employees must be legally authorized to work in the United States. Verification of employment eligibility required at the time of hire. Visa sponsorship is not available for this position .
Skills and Abilities
Working knowledge of quality systems and regulatory requirements (21 CFR Parts 210 and 211).
Strong analytical and problem solving skills.
Skilled in risk assessment, root cause analysis, and complaint and CAPA system execution.
Strong written communication skills and technical writing, including the demonstrated ability to write clear, concise reports and business correspondence.
Skilled in product stability; real time, accelerated and annual stability
Exceptional project and time management skills enabling the candidate to multi-task several initiatives simultaneously while adhering to aggressive timelines.
Proficient computer skills (MS Windows, MS Office applications), database management, Adobe Acrobat Professional, SharePoint and Minitab.
Well-developed interpersonal skills, including the ability to manage and respond to a variety of situations in a friendly, timely and collaborative manner.
Exceptional organizational skills and keen attention to detail.
Highly flexible and adaptable. Ability to work independently with minimal supervision in a fast paced multitasking environment.
Bachelor’s Degree, College Diploma, or Equivalent (Required)
More about Product Supply (PSO)
The Product Supply Organization (PSO) is an inclusive, diverse global community of leaders. Our team is responsible for sourcing, making and shipping some of the world’s most trusted household products. In our organization, safety is paramount and innovation a must. Join us if you want to keep growing professionally and make an impact in the lives of millions of homes.
More About Clorox
The Clorox Company (NYSE: CLX) is a leading multinational manufacturer and marketer of consumer and professional products with approximately 8,800 employees worldwide and fiscal year 2020 sales of $6.7 billion. Clorox markets some of the most trusted and recognized consumer brand names, including its namesake bleach and cleaning products;
Liquid-Plumr® clog removers
Poett® home care products
Fresh Step® cat litter
Glad® bags, wraps and containers
Hidden Valley® dressings and sauces
Brita® water-filtration products; Burt's Bees® natural personal care products
RenewLife® digestive health products
Rainbow Light®, Natural Vitality™ and NeoCell® dietary supplements.
The company also markets industry-leading products and technologies for professional customers, including those sold under the CloroxPro™ and Clorox Healthcare® brand names. Nearly 80% of the company's sales are generated from brands that hold the No. 1 or No. 2 market share positions in their categories
Making a positive impact
Clorox is a signatory of the United Nations Global Compact and the Ellen MacArthur Foundation's New Plastics Economy Global Commitment. The company has been broadly recognized for its corporate responsibility efforts, named to the 2020 Axios Harris Poll 100 reputation rankings, Barron's 2020 100 Most Sustainable Companies list, and the Human Rights Campaign's 2020 Corporate Equality Index, among others. In support of its communities, The Clorox Company and its foundations contributed more than $25 million in combined cash grants, product donations and cause marketing in fiscal year 2020. For more information, visit TheCloroxCompany.com at http://thecloroxcompany.com/ , including the Good Growth blog, and follow the company on Twitter at @CloroxCo
The Clorox Company and its subsidiaries is an EEO/AA/Protected Veteran/Disabled/LGBT employer.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled