Bristol-Myers Squibb Company

Quality Operations Project Specialist

Location
Manati, PR, US
Posted
Apr 12, 2018
Ref
R1504031
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Accountable for assuring that the Strategic Quality/PMO projects, OpEx initiatives and Quality Risk Management (QRM) Program in Manati Quality Operations department are being executed under the BMS standards, procedures and policies in order to increase Customer service, reduce product cost, minimize cycle times and risk associated to the process, testing and facilities. The incumbent will be point of contact across Manati Quality Operations for communication Strategic/capital projects, Quality Plan update, OpEx and PMO. Leads QRM certification in Quality Operations department. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Major Duties and Responsibilities:

- Leads and drives different Operational Excellence initiatives in the Quality Operations department based upon impact to Manati Strategy goals and objectives.

- Provides guidance in the safety program within QC laboratories reviewing monthly audits and Job Hazard assessments.

- Monitors QC laboratories OpEx initiatives and Quality/PMO projects.

- Recommends and makes changes to documents (e.g. SOP's, protocols, Testing Standard, methods, monographs, etc.).

- Ensure that these documents are aligned with the practice and BMS policies.

- Certifies Quality Operations personnel in QRM procedure and program.

- Recommends Lean milestones such as standardize work, visual aids, 5's, spaghetti diagram etc. and audits it sustainability for all areas in Quality Operations department.

- Leads and Performs special projects such as; QRM program revamp, Batch Characteristic, LIMS, Smartlab,, new initiatives for sample flow and reagents inventory.

- Determines requirements for documentation, materials, trainings and equipment modifications within the QC laboratories during the new product introduction process.

- May performs Quality Project liaison role as the backup when the QA Project Manager is not available.

- Gather and evaluate data to reduce waste and variability in the current process such as testing standard change management.

- Leads structured process when solving problems, cause and effect, trending and define root cause for determine QO Project charters.

- Collaborates with Quality/PMO and OpEx initiatives in the sites and other sites within GBQ network as needed in Kaizen and Mapping process exercises.

- Engages with Site Strategic Projects organization to drive risk management elements through product and process lifecycle ensuring cGMP and BMS policies and directives standards for Final QA approval up to project completion.

- Ensures tracking and site adherence to Project deliverables for new system or process with business process owner.

- Enforce critical thinking in the Project management process specifically during scope, problem statement, analysis tools, risk assessment evaluation and milestones determination to guarantee that opportunities are properly addressed.

- Works with QO area leaders to understand and document value streams.

- Provides input and participates during the Quality Budget / Quality Capital Projects development process.

- Create and sustain QO Projects tracking structure and tool to facilitate the GQ network communication, Manati site reporting and lessons learned culture deploy.

- Prepare meeting minutes, mapping process flows, presentations and project charters using operational excellence techniques supporting all Quality Operations, PMO projects and initiatives.

KNOWLEDGE / SKILL

- Bachelor Degree in Science
- Minimum five (5) years of experience in a Quality Operations.
- Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them.
- Ability to communicate effectively with wide range of personnel, written and verbal.
- Strong technical writing and interpretation skills related in QRM.
- Ability to create / organize cGMP systems and procedures based on regulatory compliance requirements
- In depth analytical thinking, statistical analysis, problem solving and Lean skills.
- Knowledge to collect and document data and/or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.).
- Knowledge of computers applications (Microsoft Word, Excel, Power Point)
- Excellent interpersonal skills and team work oriented
- Excellent communications skills in Spanish /English
- Lean Six Sigma Yellow/Green Belt required.
- Proficient in Project Management Skills.
- Proficient in cGMPs, FDA and EMA regulations and requirements.