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Technical Operations Support Specialist

Quva Pharma

This is a Full-time position in Temple, TX posted September 3, 2021.

Position Overview:

This position provides hands on support in the generation and execution of Technical Operations deliverables to include, but not limited to, product transfer gap assessments (based on sending site information), process development/proof of concept studies, Bloomsbury Product Introduction Forms, process validation studies, API Conversions, process investigations, and process improvement initiatives.

This individual will also provide support in the detection and resolution of difficult to detect process errors and frequently interact with individuals from other functions within the company.

This position requires knowledge of existing processes and a comprehensive acquaintance with generation and approval of cGMP documentation to include Master Batch Records and Validations.

Responsibilities may include:
Report directly to the Manager, Technical Operations with minimal supervision in the execution of assigned deliverables required to fulfill Tech Ops commitments Generate technical information, often in the form of process data, required to fulfill assigned deliverables without the support of established procedures Generate and execution of development, validation, and engineering documentation necessary to formally capture product introductions, process investigations, and process improvements Generate Knowledge Transfer and Training Plans to support the transition of knowledge from the Tech Ops community into routine production environment Provide compounder and formulator training with respect to new products or processes as necessary to fulfill planned knowledge transfer requirements Engage with Pharmacy Services, Quality, Operations, and R&D to support development and approval of Master Batch Records and associated labels for new products being introduced at the site Complete training curricula and any Competency Assessment requirements to perform routine product formulation process steps to ensure new products and/or processes are designed in accordance with current standard operating procedures Routinely communicate with Tech Ops individuals at other QuVa Pharma sites to leverage process knowledge to ensure similar process are aligned and consistent with best practices and company standards Generate change control documentation as necessary to support introduction of new products or process improvements Provide experienced input for continued process improvement initiatives designed to support efficiency Provide experienced input with Root Cause Investigations related to process variances or customer complaints and lead the execution of Root Cause Analysis cross functional teams as assigned.

Once completed, summarize the root cause investigational activity in the form of cGMP investigation report Support the development and update of Standard Operating Procedures required to implement new products or processes and/or process improvements Provide Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to scheduled technical operations lots or routine production performance concerns
Qualifications:
Legally authorized to work in the job posting country Minimum High School Diploma Minimum three (3) years of relevant experience Minimum 3 years experience in the manufacture, and distribution of sterile Pharmaceutical/Biological products Experience in site-based manufacturing, quality operations, and/or research and development roles, is required.

Experience at multiple sites and across multiple functions is preferred Execution of product transfer and validation of formulation, manufacture, and distribution of sterile Pharmaceutical/Biological products Experience with product and/or process validation concepts is preferred Incumbent must possess extensive knowledge of cGMPs Good working knowledge of regulatory guidance as it pertains to APIs and injectable drug products Experience in Aseptic Operator Qualification and Process Simulation programs Experience with personnel and material flow patterns required for sterile environments
To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S.

positions must be a U.S.

citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C.

1160(a) or 1255(a)(1).

Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

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