Quality Assurance Specialist III
Company: Planet Pharma
Location: New Haven
Posted on: June 23, 2022
Job Description:
Position Summary:Specialist III for QA External Manufacturing
will be responsible for providing oversight of quality activities
associated with drug substances, drug products, devices, and
finished product manufacturing processes at contract manufacturing
organizations. The Sr. Specialist contributes and supports the
completion of milestones associated with specific projects and
supports ongoing quality assurance responsibilities in support of
Contract Manufacturing oversight and quality systems including
Change Control, Deviations and CAPA's. Sr. QA Specialist/Manager
performs all responsibilities in accordance with company policies,
procedures, and regulations.Responsibilities:
- Serve as Quality Assurance support and SME for Drug Substance,
Drug Product, and Finished product manufacturing maintaining
knowledge of industry standards and regulatory requirements to
ensure all drug manufacturing, storage and shipping activities are
compliant
- Providing oversight of GMP systems completed by CMO's and
External Supply Chain function related to Drug Substance, Drug
Product, Devices, and Finished Products.
- Provides oversight to continuous quality system improvements
and supports implementing improvements at CMO's in compliance,
Preventive Maintenance, Deviation Management and Change Control
Programs as they impact Alexion
- Works closely to build relationships with contract
manufacturers' quality personnel
- Works closely with internal cross-functional impacted areas,
such as Global Clinical Supply, External Plant Operations, CMO
Management, CMC/Regulatory Affairs and Technical Services to
resolve open issues in a timely manner resulting from record
reviews and deviation events
- Responsible for reviewing contractor documents i.e. protocols,
batch records, deviations and change controls to ensure that they
comply with Alexion procedures and meet Alexion standards
- Responsible for Product release activities.
- Approve Alexion specific standard operating procedures and
controlled documents issued by contract manufacturing
organizations
- Support contract manufacturing organization audits, including
pre-approval inspections
- Develop and issue quality metrics pertaining to the process
quality activities
- Trends and analyses quality aspects of technology transfer
activities to measure key performance indicators, identifies areas
for continuous process improvements and risk mitigation, compiles
and presents analyses at Quarterly Management Review meetings,
proposes and leads team implementation of appropriate CAPA
- Reviews and assesses deviations; includes performing risk
assessments, participating in root cause analysis investigations,
tracking, follow-up, and reporting/trending
- Review Corrective and Preventive Actions (CAPA); includes
tracking, follow-up, and reporting/trending and evaluating CAPA for
effectiveness
- Supports Quality Assurance to guide various projects and
technical meetings, as neededQualifications:Must have
experience/knowledge of drug substance/product/finished product
manufacturing processes in a cGMP environmentMust have knowledge of
industry best practices and current regulatory expectations
concerning drug substances, drug products, and finished product
manufacturing.Experience working with contract manufacturing
organizationsAbility to provide project leadership and guide
successful completion of Quality projectsExcellent written and
verbal communication and negotiating skillsRisk assessment and risk
managementAbility to exercise judgment with defined procedures and
practices to determine appropriate actionAbility to prioritize
daily activities in order to meet internal and external customer
needs on time of established timelines in a fast-paced
environmentAbility to monitor and report on assigned tasks, goals,
and objectives.Education:Bachelor's degree required; preference is
given to candidates with advanced degrees; Two or more years of
cGMP experience preferred; consideration will be given to other
relevant experience and education.
Keywords: Planet Pharma, New Haven , Quality Assurance Specialist III, Other , New Haven, Connecticut
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