Pine Pharmaceuticals · 1 day ago
MQA Conformance Specialist
Tonawanda, New York, United States
Full-time
Onsite
Senior Level
$31/hr - $31/hr
5+ years expPine Pharmaceuticals is seeking an MQA Conformance Specialist to support pharmaceutical manufacturing and visual inspection operations. The role involves conducting quality assessments, monitoring compliance, and supporting investigations to ensure adherence to cGMPs and internal quality standards.
Health CareManufacturingPharmaceuticalRetail
Responsibilities
Conduct routine and targeted audits of manufacturing operations, including cleanroom practices, gowning, aseptic technique, line clearance, material flow, and visual inspection processes
Support other audits across departments, as requested by Quality leadership
Provide support for review and approval of work orders
Monitor manufacturing and inspection activities for adherence to cGMP, SOPs, and internal quality standards
Identify trends, recurring issues, or compliance gaps in deviations, inspection results, or environmental monitoring data, and escalate as appropriate
Support investigations of deviations, non-conformances, and audit findings; assist in root cause analysis and CAPA documentation under guidance from QA management
Ensure quality records, audit reports, and documentation are complete, accurate, and compliant with ALCOA+ principles
Assist in preparation and support for regulatory inspections, including document review and on-floor observation
Reinforce GMP expectations, cleanroom behavior, and visual inspection procedures with manufacturing personnel
Track training compliance for manufacturing and inspection teams and highlight gaps to management
Collaborate with cross-functional teams (Manufacturing, MQA, Microbiology, Engineering) to strengthen quality controls and inspection readiness
Contribute to continuous improvement initiatives by identifying opportunities to enhance audit processes, compliance monitoring, and overall manufacturing quality
Ensure investigations are thorough, timely, scientifically sound, and appropriately documented
Evaluate root cause analyses and effectiveness checks to ensure sustainable corrective and preventive actions
Author and ensure completion of NONC investigations, issue reviews, action Items and CAPA for risk mitigation as needed
Effective communication and collaboration with cross functional teams, QA management and conduct and lead investigative interviews
Other activities/tasks as dictated by departmental and organizational needs
Qualification
Required
Bachelor's degree (Biology, Chemistry or related science) and a minimum of 5 years related experience including a working knowledge of GMPs and pharmaceutical manufacturing or an Associate's Degree in a related field plus a minimum of 6 years of experience in a QA pharmaceutical manufacturing role
May consider candidates with a High School Diploma plus a minimum of 10 years of pharmaceutical manufacturing experience and specializing in a related field such QC data review
Technical experience of working at pharmaceutical manufacturing facility with the ability to understand and interpret regulatory requirements is required, as well as an understanding of aseptic technique and visual inspection processes
Experience reviewing and analyzing data to ensure compliance and support investigations within a regulated Quality Management System
In-depth knowledge of Regulatory/Compendial requirements, pharmaceutical quality, and Quality Systems, with broad experience and exposure to best practices is required
Experienced motivator, communicator and coach with strong sense of working in a team environment
Proficient time manager
Experience in conducting and/or directing investigations and internal/external audits a plus
Ability to handle multiple and changing priorities and tight deadlines while remaining detail oriented
Experience writing deviation/investigation reports and drive CAPA's to completion
Knowledge & experience with use of current software MSOffice (e.g., Word, Excel, PowerPoint, etc.)
Excellent time management skills
Excellent attention to detail
Understanding of Quality requirements and Pharmaceutical Regulations including, but not limited to 21CFR211, 21CFR11, Good Documentation Practices, and ALCOA+
Ability to adhere to standard operating procedures and policies
Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required
Able to work independently and as a team
Preferred
Knowledge and experience with use of electronic quality management systems preferred
MasterControl knowledge is a plus
Company
Pine Pharmaceuticals
Pine Pharmaceuticals manufactures and supplies anesthetics, antibiotics, intranasal solutions, steroids, topical ophthalmic & IV solutions.
201-500 employees
Funding
Current Stage
Growth StageRecent News
Business Journals
2023-07-28
Business Journals
2023-05-23
2023-05-11
Company data provided by crunchbase