Stacey Johnson
5 Lucerne Street, Springvale,Maine
Summary
Enthusiastic and detail-oriented professional with extensive experience in pharmaceutical manufacturing and quality assurance. Proven track record of leading successful teams to meet and exceed regulatory expectations and organizational goals. Skilled in developing and implementing efficient processes and training programs to enhance product quality and safety.
Overview
12
12
years of professional experience
Work History
Senior Consultant
i-Pharm Consulting
New York, NY
10.2022 - 06.2024
- Identified areas for improvement, narrowing focus for decision-makers in making necessary changes.
- Assisted with continuous business improvement based on learnings from client implementation, previous experiences, and fresh ideas.
- Managed multiple projects simultaneously while adhering to tight deadlines.
- Performed risk assessment analysis to identify areas that require special attention and developed strategies for improvement.
- Ensured accuracy of documentation related to all quality assurance processes and procedures.
- Fostered a culture of quality across the organization by promoting awareness and understanding of quality standards and their importance.
Senior Manager GMP Operational Quality - External Manufacturing
Vertex Pharmaceuticals
Boston, MA
07.2021 - 09.2022
- Monitored compliance with industry regulations and company policies to mitigate risk.
- Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
- Participated in recruitment initiatives by interviewing potential candidates and selecting suitable hires.
- Reviewed completed work to verify consistency, quality, and conformance.
- Collaborated with external vendors to negotiate contracts that met company requirements while minimizing costs.
- Reported to executive leadership on performance metrics, challenges, and strategic opportunities.
Quality Compliance Supervisor
Tom’s of Maine, Inc. (a Subsidiary of Colgate-Palmolive)
Sanford, ME
08.2016 - 07.2021
- Developed and maintained quality documentation, including quality manuals, procedures, and records.
- Monitored production operations for compliance with good manufacturing practices and regulatory requirements.
- Maintained records of all inspection activities in a secure database system.
- Provided training on GMP, ISO 9000, and other relevant regulatory guidelines to staff members.
- Tracked non-conforming material and products through disposition process.
- Collaborated with cross-functional teams including engineering, production, and logistics departments to develop effective solutions for quality related problems.
Quality Manager - Drug Product Manufacturing
Pfizer, Inc.
Pearl River, NY
09.2013 - 05.2016
- Assigned work and monitored performance of project personnel.
- Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
- Performed internal audits of production processes to identify areas of improvement and non-conformities.
- Implemented quality control measures to uphold company standards.
- Conducted training sessions for employees on quality assurance processes, techniques and tools.
- Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
Aseptic Compliance Lead - Quality Control
Pfizer, Inc.
Pearl River, NY
01.2012 - 09.2013
- Participated in internal reviews and audits of Quality Assurance activities as needed.
- Provided technical support for manufacturing operations by troubleshooting equipment malfunctions related to product quality issues.
- Evaluated existing processes for opportunities to improve efficiency while maintaining high levels of product quality assurance.
- Analyzed nonconforming materials to determine root cause analysis and corrective action plans.
Education
MBA - Management, International Business Certificate
Iona College, Hagan School of Business
New Rochelle, NYBA - Philosophy, Studio Art, Creative Writing
Manhattanville College
Purchase, NYSkills
- Quality Assurance
- Regulatory Compliance
- Process Improvement
- Team Leadership
- Training Development & Delivery
- Consulting
- Domestic and International GMPs
- Sterilization Techniques & Procedures
- Microbiology
- Cleanroom Management
References
References provided upon request.
Personal Information
Irish Citizenship
Timeline
Senior Consultant
i-Pharm Consulting
10.2022 - 06.2024
Senior Manager GMP Operational Quality - External Manufacturing
Vertex Pharmaceuticals
07.2021 - 09.2022
Quality Compliance Supervisor
Tom’s of Maine, Inc. (a Subsidiary of Colgate-Palmolive)
08.2016 - 07.2021
Quality Manager - Drug Product Manufacturing
Pfizer, Inc.
09.2013 - 05.2016
Aseptic Compliance Lead - Quality Control
Pfizer, Inc.
01.2012 - 09.2013
MBA - Management, International Business Certificate
Iona College, Hagan School of Business
BA - Philosophy, Studio Art, Creative Writing
Manhattanville College
Similar Profiles
Jihyun LimJihyun Lim
Quality Control Analyst at BC World PharmQuality Control Analyst at BC World Pharm
YOUNGSEON CHOIYOUNGSEON CHOI
Managing Director at Samsung Pharm Inc.Managing Director at Samsung Pharm Inc.
Amit RomAmit Rom
Medical Cannabis Pharmacist Manager at Leon PharmMedical Cannabis Pharmacist Manager at Leon Pharm