Sheila Province
E: **************@*****.*** L: Stroudsburg, PA P: (347) 422- 2627
RELEVANT EXPERIENCE
Sanofi Pasteur Inc. Swiftwater, PA Senior Production Technician October 2015- December 2022
Conducted investigations of deviations and performed root cause analysis to identify and resolve issues that could impact the quality of the product and implemented corrective and preventive actions as needed.
Participated in continuous improvement projects to enhance production efficiency and quality and monitored and evaluated manufacturing processes to identify opportunities for improvement.
Trained new hires and personnel on proper operational procedures, cGMPs, safety procedures, and company policies, ensuring compliance with regulations and guidelines, and provided guidance and leadership when the supervisor was unavailable.
Operated, maintained, and performed tank integrity checks on a variety of production equipment, including pumps, filtration systems, cleanroom equipment, portable filling lines, and tanks, ensuring proper functioning, calibration, and cleanliness.
Reviewed, approved, developed, and revised SOPs (Standard Operating Procedures) and batch records for completeness, accuracy, and compliance with cGMP requirements, and ensured that all personnel involved in manufacturing operations are trained on the most current SOPs and batch records, with up-to-date records readily available.
Collaborated with other departments (e.g., Quality Assurance, Engineering, Manufacturing) to identify and address any discrepancies or issues related to SOPs and batch records, and participated in audits and inspections of manufacturing facilities, providing documentation as requested by auditors or inspectors.
Performed Clean-In-Place (CIP) and Steam-In-Place (SIP) operations for portable filling lines and tanks, completed Aseptic Technique training, and performed Environmental Monitoring duties including EM Set-up, Weekly and Monthly monitoring using Settle Plates, Lasairs, and SMA Samplers.
Achieved completeness of line clearance by verifying room preparation for each pharmaceutical parenteral batch and ensured compliance with cGMP's in an aseptic environment as a Qualified Trainer, Parenteral Filling, Labware/LIMS, and Steam, WFI (Water for Injection), Deionized Water, and Clean Steam Sampling.
Provided product filter maintenance and testing, sampling portable tanks for filling lines, and manipulated and assembled precision relating components for 100 class parenteral filling under a laminar flow environment.
Aseptic Cleaning Technician (ACM) February 2004- October 2015
Cleaned and sanitized aseptic manufacturing rooms, equipment, and components according to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs).
Conducted environmental monitoring and collected samples for testing, including air, surface, and water samples, in compliance with regulatory requirements.
Assisted in the preparation and set-up of aseptic filling and packaging equipment, ensuring cleanliness and sterility.
Maintained inventory and stock of cleaning supplies and equipment, ordering replacements as needed to ensure uninterrupted cleaning operations.
Documented all cleaning activities and environmental monitoring results accurately and timely in appropriate logbooks or electronic systems.
Participated in investigations of deviations and non-conformances related to cleaning and sanitation and implemented corrective and preventive actions as needed.
Maintained a safe and clean work environment, adhering to safety protocols and wearing personal protective equipment (PPE) as required.
Trained new hires on cleaning procedures, safety practices, and GMPs, ensuring compliance with regulations and guidelines.
Bayada Home Health Care East Stroudsburg, PA
Nursing Assistant October 2013 – May 2014
Provide compassionate and professional care to patients in their homes, under the direction of a registered nurse.
Assist with activities of daily living, including bathing, dressing, grooming, and toileting.
Monitor patients' vital signs, such as blood pressure, temperature, and pulse.
Administer medications as directed by the nurse.
Assist with ambulation and transfer of patients.
Provide emotional support to patients and their families.
Document patient care activities and report any changes in patients' condition to the nurse.
Communicate effectively with other members of the care team, including nurses, therapists, and social workers.
Adhere to all policies and procedures related to patient care, including infection control and safety protocols.
Attend in-service education programs and participate in ongoing training and development to enhance your skills and knowledge.
Maintain confidentiality of patient information and comply with HIPAA regulations.
EDUCATION
Municipal Training Center Brooklyn, NY
Nursing Assistant 2000
Jamacia Business School Port-Au Prince, Haiti
Business 1994
College Classic of Port-Au-Prince Port-Au Prince, Haiti
High School Diploma 1993