PAULA HIGDON
New Market,AL
Summary
Seeking a professional position with leadership responsibilities including problem solving, planning, organizing and productively meeting expectations to achieve corporate goals.
A growth-oriented and highly talented Manufacturing Quality specialist with a strong background in pharmaceutical quality control, cGMP compliance, sampling and testing materials according to ANSI/ASQC standards, understanding and adhering to specific detailed department Standard Operating Procedures, and ensuring specifications written for materials are accurate.
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
20
20
years of professional experience
Work History
Integration Specialist Quality
Boeing
08.2018 - Current
- Developed custom connectors to facilitate seamless data flow between enterprise applications.
- Increased user satisfaction by identifying opportunities for process improvement within integrated systems.
- Maintained up-to-date documentation on all integration projects, allowing for easy reference and future enhancements.
- Assisted in the selection of appropriate middleware solutions based on project requirements and budget considerations.
- Inspected quality of products, taking note of functionality, appearance and other specifications.
- Communicated with production team members about quality issues.
- Inspected incoming and outgoing materials for accuracy and quality.
- Collaborated with production staff to establish and meet quality standards
- Evaluated components and final products against quality standards and manufacturing specifications.
- Completed precise measurements using special tools.
- Ensured the accuracy of measurement tools and equipment by performing regular calibration checks and maintenance.
- Actively participated in regular audits to verify compliance with industry regulations and company policies, ensuring continued certification and enhanced credibility within the market.
- Performed root cause analysis to identify and resolve defects, improving quality standards.
- Enhanced product quality by conducting detailed inspections of incoming materials, ensuring alignment with company standards.
Senior Quality Associate, Incoming Materials
PAR PHARMACEUTICALS
01.2010 - 01.2018
- Responsible for completing all Quality Assurance Incoming Inspection requirements related to sampling, testing, and determining final disposition of all packaging and labeling components used to manufacturer/package pharmaceutical products. Also responsible for the inventory control and issuance of all labeling components used to produce pharmaceutical batches. Provide leadership and assistance to associates within the department as needed.
- Detailed Responsibilities Include:
- Identifying correct specifications to be used to perform testing of components received.
- Accurately maintain and file test documents that are routinely monitored and used to determine testing requirements.
- Perform sampling of all components according to ANSI/ASQC standards while also ensuring samples selected are representative of the entire shipment received.
- Perform component testing using various manual measurement equipment such as calipers, micrometers, thickness gauges, weight scales, induction sealers, etc.
- Use of “Master Labeling Proofs” to perform comparison analysis on all labeling literature.
- Document and compare test results with established specifications to determine if the composition, dimensions, and visual attributes of each component are acceptable.
- Paula Higdon, Professional Experience...Continued
- Review all test data and perform final disposition of each components to identify the shipment received to be acceptable/not acceptable for production use.
- Perform all inventory control transactions within the ERP System to post completion of testing and results of final disposition.
- Using ERP Inventory Control System, create pick lists to pull released components to be used during the production of finished product.
- Accurately maintain inventory levels of components as they are issued to and returned from production batches. Inventory levels maintained both manually and within the ERP Inventory Control System.
Quality Assurance Auditor
PAR PHARMACEUTICALS
01.2005 - 01.2010
- Responsible for conducting routine quality audits of the production processes to ensure cGMP requirements are being followed and batch production records are accurately followed and completed.
- Detailed Responsibilities Included:
- Inspection of all manufacturing and packaging equipment prior to use.
- Ensure all materials pulled for a production order were consistent with the production requirements.
- Perform routine “in process” checks on finished product to ensure all specifications were being met.
- Pulled and delivered samples to laboratory for analytical testing.
Education
High School Diploma -
Scottsboro High School
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Northeast Alabama Community College
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Calhoun Community College
Skills
- An experienced team oriented individual with the ability to both receive as well as initiate instructions intended to deliver a quality product in a safe, quality oriented structure that meets the regulated standards of the company
- Analytical thinking, decision making, and problem solving skills with strong cGMP compliance experience
- Excellent Personal Communication skills
- Strong leadership trait associated with providing extensive training ensuing successful task completions
- Creating and executing detailed specifications used to perform “meets/does not meet” testing criteria used to determine the disposition of external purchased materials
- Experienced in using manual testing equipment such as calipers, micrometers, weight scales, thickness gauges, and induction sealers to ensure materials meet pre-established measurements
- Able to read and interpret AQL slide scales to determine “Accept /Reject” limits
- Perform proof reading analysis to ensure literature for products are accurately produced without error
- Efficient in Word, Excel, PowerPoint and other computer programs/software
- Fluent in various inventory control systems such as SAP and MAPICS
- Develop and maintain professional and interpersonal relationships with direct customers and support groups associated with the production performance
- Proficient in Microsoft Word, Excel, and PowerPoint
- 15 years experience in Quality Assurance
- Organized and Detail Oriented while maintaining productivity
- Ability to work in a team environment to meet goals
- Qualified Department Trainer
Timeline
Integration Specialist Quality
Boeing
08.2018 - Current
Senior Quality Associate, Incoming Materials
PAR PHARMACEUTICALS
01.2010 - 01.2018
Quality Assurance Auditor
PAR PHARMACEUTICALS
01.2005 - 01.2010
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Northeast Alabama Community College
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Calhoun Community College
High School Diploma -
Scottsboro High School
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