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Carol A. Jones Regulatory, Compliance and Quality Professional

** *. ****** **.

Vineland, NJ 08360

609-***-****

ad2mry@r.postjobfree.com

QUALIFICATIONS:

** *****’ experience in Regulatory Affairs. Strong working knowledge of FDA and USDA regulations and cGMP’s. Experienced in FDA regulated electronic submissions, with emphasis on CMC. Experienced proofreader. Experienced in Microsoft Word, Excel, Access, Power Point, Zetadocs and Abode. Trained employees on policies and procedures regarding Regulatory documentation practices and compliance. Ability to work effectively and efficiently with little or no supervision. Exceptional verbal and written communication skills. PROFESSIONAL EXPERIENCE:

Innovation Foods – Millville, New Jersey

Quality Compliance Specialist: 5/23 to present

Manage all internal and external inspections/regulatory visits. Leads audit preparation activities accompanies inspector- and completes necessary reports and posting. Performs follow up activities to non-conformances found and provides responses as appropriate. Plans, define and directs the Site auditing control program to ensure compliance to all procedures and policies and to regulatory federal and local laws. Including identification of facility Quality KPI’s corrective/preventive action and continuous improvement initiatives. Train and mentor site Auditors to ensure program goals are met. Manage execution of site GMP and HACCP programs. Manage Quality systems and support the updating of Quality refresher training (e.g. GMP’s, allergens, hold/release) as needed. Organize and maintain a quality document system. Ensure Quality policies are understood and communicated to site employees. Masis Co. @ ADM/Eatem Foods – Vineland, New Jersey Regulatory Affairs Contractor: 3/20 to 5/23

Kosher and Organic Food certifications. Work closely with procurement and raw material vendors to obtain documents required for re-certification. Submit information to various agencies to maintain certifications and remain in compliance. Prepare regulatory documents including, but not limited to allergen statements, country of origin statements, GMO statements, SDS sheets, nutritional information. Research and complete customer inquiries including questionnaires. Work within Trace Gains to provide customer requested information. Work closely with Regulatory Technical manager and provide support with specific and critical programs and projects. Responsible for Food Safety and Quality. Teligent Pharma, Inc. – Buena, New Jersey

Regulatory Affairs Associate: 7/19 to 1/20

Ensure labeling remains compliant with FDA. Monitor FDA website and other resources for changes to Reference Listed Drug (RLD) labeling effecting approved products and products pending approval. Monitor the expiration of RLD patents and exclusivities affecting labeling content, initiating necessary revisions. Monitor and interpret FDA regulations, policies, and guidelines as they pertain to labeling issues, and correctly apply them as appropriate. Manage artwork related changes to facilitate review and approval process for all artwork/labeling from development through final proofs. Evaluate content of labeling changes. Maintain artwork files both hard copy and electronic. Monitor, evaluate and recommend improvements to labeling process, system tools and/or procedures. Work with Supply Chain regarding stock replenishment to ensure most current and up-to-date labels are approved for orders. Assemble PADERS for submission via Global Submit. Update State licenses and maintain accordingly. 2

ADM/Eatem Foods – Vineland, New Jersey

Associate Regulatory Specialist: 2/17 to 7/19

Regulatory Administrator: 2/12 to 1/17

Prepare regulatory documents including, but not limited to allergen statements, country of origin statements, GMO statements, SDS sheets, nutritional information. Research and complete customer inquiries. Work with customer specific portals to provide required/requested product information/documentation. Assist with the writing of SSOP’s for production area and assist with SQF (Safe Quality Foods) audits. Revise finished product specifications; create new product specifications as required. Create and/or revise product labeling and submit it to USDA for approval. Print labels for review and approval and support labeling department regarding label changes/revisions and new product labeling. Write work instructions for specified departments Responsible for Food Safety and Quality. HACCP Certified. Cumberland County Board of Social Services - Vineland, New Jersey HSS1 - Investigations: 6/08 to 1/12

Review monthly case load report to determine cases requiring recertification. Set appointments accordingly. Case file management. Review case for relevant information and history. Analyze computer databases for supporting documentation. Meeting with clients. Prepare budget worksheet to establish eligibility. Complete required forms and submit to supervisor for approval. Wage verifications. Develop an understanding of state and local regulations/citations pertaining to eligibility. Assist in training of new hires. Rural Opportunities, Inc. - Vineland, New Jersey

Health and Disabilities Administrator: 2/08 to 6/08 Assist Director in the planning, implementation, and coordination of comprehensive health and disabilities service programs. Review and monitor center data and provide reports. Develop a complete understanding of local, state, and federal regulations and application of responsibilities. Assist in the development of program policies and procedures. Contact state and local health agencies regarding services/screenings availability. Program monitoring, training, and technical assistance.

URL/Mutual - Philadelphia, Pennsylvania

Labeling Compliance Manager: 9/07 to 10/07

Manage activities to ensure labeling remains compliant with FDA and other regulatory requirements. Monitor FDA website and other resources for changes to Reference Listed Drug (RLD) labeling affecting company’s generic approved products and products pending approval. Monitor the expiration of RLD patents and exclusivities that affect labeling content of Mutual’s products, initiating necessary revisions and file labeling supplements as needed. Monitor and interpret FDA regulations, policies, and guidelines as they pertain to labeling issues, and correctly apply them as appropriate to company’s products. Supervise the activities of Labeling Compliance Associate/Coordinator to ensure the timely, correct preparation and/or revisions of labels and inserts. MANPOWER (Alcan Packaging) - Millville, New Jersey Quality Assurance Coordinator: 4/07 to 9/07

Assist with customer complaint investigations, questionnaires and maintain files. Track/trend customer complaints. Prepare and submit findings regarding customer complaints. Enter audit information into database and maintain files. Gather information and assemble validation books for production machinery. Enter training records into training database. Some experience working with SAP systems. Lohmann Animal Health International - Vineland, New Jersey Regulatory Affairs Associate: 1/05 to 4/06

Regulatory review of approved product labeling, inserts (circulars) and cartons. Submit new and revised labeling to the USDA. Revise, submit changes and complete annual review updates of Production Outlines, Plot Plans and Blueprint Legends. File and maintain state licenses, including renewals. Prepare, submit, and maintain files for permits and product licenses. Organize and conduct Production Outline review meetings. Regulatory support for Safety Review committee and International Registrations. Alternate company liaison to USDA. 3

Miza Pharmaceuticals USA, Inc. - Fairton, New Jersey Regulatory Affairs Manager: 11/01 to 1/03

Regulatory review and approval of product labeling, inserts and carton proofs. Prepare and submit Annual Reports. File and maintain Medical Device Drug Listings, Drug Establishment Registration including Medical Device Establishment Registration. Create and revise Regulatory Affairs SOP’s. Maintain ANDA filing system. File and maintain State License renewals.

Aspire Pharmaceuticals, Inc. (Division of Andrx) - Davie, Florida Regulatory Affairs Specialist: 6/01 to 11/01

Prepare, review, and submit ANDA’s. Electronic CMC preparation and submission. Also, prepare and submit side-by- side comparisons of product labels and inserts for submissions. Proofread product labels and inserts. Coordinate with out-of-state divisions on requirements for Drug Formulary. Watson Laboratories, Inc. (formerly Royce Laboratories)- Miami, Florida Regulatory Affairs Associate: 11/98 to 5/01

Prepare and submit electronic submissions with emphasis on CMC. Assist in preparation and submission of ANDA’s including amendments and supplements. File drug listings, annual reports, ADE reports (periodic and 15-day safety reports) and handle Customer Complaints. Proofread product labels and inserts. Also, prepare and submit side-by- side comparisons of product inserts for submissions. Train Regulatory staff. Regulatory Affairs Assistant: 5/95 to 10/98

Prepare and submit Annual Reports and submit new drug product information to State Formularies and Agencies such as Red Book, Facts and Comparison, etc. Assist in preparation and submission of ANDA’s. Complete ARCOS forms and quotas for controlled substances. File and maintain State License renewals. Production QA/QC Secretary: 12/91 to 4/95

Revise Manufacturing master’s and issue batch records. Revise, issue and maintain SOP’s, STP’s and change control systems. Assist in preparation and submission of ANDA’s. Update and maintain DEA State licenses for Drug distributors and Wholesalers. Prepare and submit Poisondex (Micromedex) forms and maintain file. EDUCATION:

Bachelor’s Degree in Behavioral Science, Wilmington University – January 2012 REFERENCES:

Available upon request