Quality Assurance Technical Support Specialist
Rockline Industries, Inc - Sheboygan, WI

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POSITION SUMMARY: The Technical Support Specialist will have overall responsibility for the oversight of the OTC and medical device development testing program, stability program (development and commercial), and the Rockline Trading externally manufactured OTC and medical device product quality and release function.

ESSENTIAL DUTIES AND RESPONSIBILITIES include but not limited to the following:
• Writes, reviews and revised SOPs associated with the stability program for development and commercial OTC products manufactured externally.
• Coordinates testing of OTC stability samples for development and commercial samples. Ensures that all stability samples and time point samples are scheduled, pulled, analyzed, and test results reviewed per SOP and protocol requirements. Maintains all cGMP required records pertaining to stability program for OTC products.
• Coordinates testing of externally manufactured OTC and medical device commercial product samples. Ensures that all testing and product release requirements are met prior to the release of product to the market.
• Collects and input product testing data for analysis and trending. Performs data analysis or assembles data for analysis by others.
• Coordinates OOS investigation for both internal and external testing. Reports to Technical Services Manager findings from investigations.
• Authors stability protocols and reports. Maintains all protocols and reports pertaining to externally manufactured OTC products.
• Performs annual product reviews for externally manufactured OTC products.
• Provides technical support as required to external manufacturers’ of OTC products. Coordinates third party or customer audits of external manufacturers of OTC products.
• Performs the release function for all Rockline Trading OTC products released to the US and Canadian market. Performs the release function for all Rockline Trading externally manufactured medical device products for the US and Canadian markets. Maintains batch records and retain samples. Performs complaint investigations on RT externally manufactured OTC or medical device products and maintains records of investigations.
• Authors specifications for externally manufactured OTC and medical device products. Processes specifications through the Rockline Global Document Management System.
• Authors and maintains quality agreements with external manufacturers of OTC and medical device products.
• Interfaces with external auditors or regulatory inspectors for externally manufactured OTC and device products. Maintains audit findings and tracks CAPA actions resulting from audits and verifies the effectiveness of corrective actions.
• Performs other duties as assigned by the Technical Support Manager.

EDUCATION, EXPERIENCE, SKILLS REQUIRED

• Bachelors degree in science or engineering, chemistry or chemical engineering preferred. Two years Quality Assurance experience in FDA regulated products, pharmaceutical experience preferred. Additional experience working in a technical and/or scientific function desired. If less than a BS degree, sufficient direct industry experience of ten years or greater and training in all key areas of job responsibilities.
• Prior experience desired in quality systems for regulated industries and in validation of processes and cleaning for OTC drugs and class 1 medical devices.
• Prior experience in external manufacturer quality system management. Quality system audit experience desired.
• Demonstrated technical writing skills.
• Strong analytical, communication, interpersonal skills.
• Ability to prioritize and coordinate activities to effectively meet critical deadlines.
• Ability and willingness to travel up to 20 percent of the year, both domestic and international.
• Computer proficiency, Microsoft Excel, Word, Windows NT, and statistical software.

Please send your resume to the following email address: hrw1@rocklineind.com