Teva Pharmaceuticals Manufacturing Science & Technology(MS&T) Specialist II in Salt Lake City, Utah
Under general supervision, performs duties in reviewing specifications and critical aspects of product and process quality. Writes validation protocols for products and records test results. Prepares final reports on the results of protocol testing and the conditions of release. Assists in conducting efficiency studies and in the identification of process improvement opportunities. Participates in project coordination activities.
Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
Provides assistance in troubleshooting to manufacturing and packaging areas.
Interfaces with Quality Assurance and Research and Development (R&D) on process requirements for new and current products.
Works in conjunction with maintenance department to identify, recommend and implement the upgrade of current equipment and the purchase of new equipment within regulatory requirements.
Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization.
Performs studies to support necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.
Assists with on-site transfer projects and product scale-up activities.
Recommends improvements in manufacturing and control systems.
Assures that protocols are approved through proper channels; writes and revises validation protocols.
Executes validation protocols per related SOPs and assures that acceptance criterion related to validation protocols are met.
Interacts with all effected personnel in the execution of protocols and gathering of test data. Assures that all test data is gathered and recorded in accordance with cGMP requirements.
Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
Writes final reports and assures that they are approved through proper channels.
Furnishes direction to technicians and manufacturing staff with regard to project requirements. Develops and communicates project timelines and status.
Provides support in investigations and other troubleshooting activities.
Prepares batch record and CMC documentation.
Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
Performs related duties as assigned.
Bachelor’s degree in Science or a related field from an accredited college or university with three (3) to six (6) years related experience; or an equivalent combination of education and experience. Graduate degree preferred.
Three (3) to six (6) years process technician or laboratory experience in a manufacturing environment.
Knowledge of or ability to learn Pharmaceutical manufacturing principles, practices and applications.
Ability to work and contribute in a positive, collaborative and dedicated team environment.
Knowledge of or ability to learn pharmaceutical product equipment qualification/calibration concepts.
Knowledge of or ability to learn Pharmaceutical raw material and finished product tests, results and interpretation.
Experience in writing clear and concise technical documents (Batch Record, Change Control, Protocols, Summary and Evaluation reports).
Project management experience; ability to simultaneously manage multiple projects, duties, and assignments.
Ability to read, write and speak English in order to complete and generate training, reports and or revise or update documentation files, databases, and logs accordingly.
Ability to lift up to 25 lbs., climb stairs & ladders, work in moderate to loud noise environment and wear GMP appropriate attire as required.
Intermediate skills in Microsoft Office Suites (Word, Excel, Access, PowerPoint, MS Project)
Intermediate statistical analysis, computations, and test methodology experience; Knowledge of JUMP or MINI TAB helpful.
Knowledge of or ability to learn current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.
Requisition # 17-19519
# Positions ..
Location US-UT-Salt Lake City
Experience (Years) 1
Category Operations - Operations Management
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.