Technical Services Associate I Position Available In Broward, Florida

Technical Services Associate

I 3.7 3.7

out of 5 stars 3250 Commerce Parkway, Miramar, FL 33025

Job Summary:

The Technical Services Associate-I will assist with and/or execute process and product improvement studies supporting commercial product lifecycle management activities for pharmaceutical products. Working collaboratively with multiple teams, the position will have the chance to make a significant impact by improving existing products, addressing manufacturing issues, evaluating new technologies and ingredients, seeking cost savings, and assisting with the development and transfer of products and processes. Job Responsibilities Carries out responsibilities in accordance with Aveva’s policies, procedures, and safety rules in accordance with local, state and federal laws. Provides support, coordinates, and executes experimental studies supporting improvements or modifications to commercial products and/or processes. Interfaces with R D, Production, Analytical Development / QC, Quality Assurance, Engineering and Regulatory departments to carry out project objectives. Assists with troubleshooting process problems and assists in process optimization. Assists with the investigation of process failures and discrepancies to assess impact upon product quality and validation status. Evaluates and implements cost-saving initiatives, including implementation of alternative raw materials, supplies, and procedures. Prepares specifications for alternative raw materials and components. Supports improvements in manufacturing and control systems including corrective and preventative actions (CAPA). Supports technology transfer initiatives within the company or with external facilities. Assists with or leads drafting of protocols to establish product and process specifications and procedures. Prepares final reports and assures they are approved through proper channels. Assists the R D department with the development and scale-up of manufacturing processes. Assists with or leads the preparation of manufacturing batch records (MBRs) and supporting documents. Provides supervision of manfactruing activities supporting R D/Tech Services projects, such as supervising beldning, coating, and packaging operations. Performs related duties as assigned.

Knowledge of:

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and other regulatory requirements. Pharmaceutical and/or Engineering principles applied to manufacturing processes that may include blending/mixing, coating, drying, converting, and packaging. Pharmaceutical quality control and manufacturing processes. Techniques of sampling, testing and measuring. Principles of mathematical and statistical computations. Basic knowledge of Statistical Process Control and Experimental Design. Speak and write fluent English with a proficiency in technical writing Personal computers and competent with Microsoft Office applications. Works as a member of a team to achieve all outcomes Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our

Values:

Collaboration, Courage, Perseverance, and Passion All other relevant duties as assigned Job Requirements Education A Bachelor’s degree in Engineering or Life Sciences from an accredited college or university Knowledge, Skills and Abilities Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution. Performing necessary projects, assignments to implement goals and objectives for effective, efficient and cost effective management of allocated resources. Functioning as an individual contributor, with minimal supervision. Ability to prepare all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.) Communicating effectively, both orally and in writing. Establishing and maintaining cooperative working relationships with those contacted (internal and external) in the course of work. Handling hazardous chemicals within established safety guidelines. Handle multiple projects and tasks. Experience A Bachelor’s degree and 1-2 years experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.