Associate, Quality Control
Company: Kal--o
Location: Richmond
Posted on: May 16, 2022
Job Description:
Job DescriptionThis position is located in Richmond, Virginia.
Remote candidates will NOT be considered.Kaléo is a new type of
pharmaceutical company, dedicated to building innovative solutions
for serious and life-threatening medical conditions. We were
founded by patients, and patients remain our central focus and
common passion.The Quality Control Associate is responsible for the
review, trending, and retention of analytical data as it relates to
commercial release, stability, and product development. This person
will work directly with various testing suppliers on a daily basis
ensuring timely execution of protocols, data integrity, and support
internal/external investigations as needed. Additionally, this
person will compile and/or review reports for submission to
regulatory agencies.The Quality Control Associate will work as part
of a highly motivated Quality Assurance team where the patient is
our focus and quality and compliance are #1. This is an opportunity
to join a team of talented professionals, work with a life-saving
product, and gain career-defining experience through exposure to
many areas of the pharmaceutical industry. As a Quality Control
Associate you will:
- Provide supplier oversight for commercial, stability, and
product development testing; including site visits, where
applicable
- Identify and escalate trends in analytical data (e.g.,
Out-of-Trend (OOT))
- Initiate, coordinate, and/or support both internal and external
investigations (e.g., Out-of-Specification (OOS))
- Develop, review, and approve analytical testing protocols (drug
and device)
- Review analytical testing data reports (drug and device)
- Maintain data collection tools used for Key Performance
Indicator (KPI) tracking
- Participate in KPI Meetings
- Prepare Statements of Work (SOW) and Purchase Orders (PO) with
suppliers as necessary
- Prepare stability sections of Annual Product Quality Reviews
(APQRs), FDA Annual Reports (ARs), and as required for various
regulatory submissions
- Review and approve supplier invoices
- Participate as an Subject Matter Expert (SME) during internal
and supplier audits, when applicable
- Develop, review, and approve departmental Standard Operating
Procedures (SOPs)
- Management of Change Requests, Issues, Deviations and
Corrective Action/Preventative Actions (CAPAs) within the Quality
Management System, when applicable
- Actively participate in QA/QC related initiatives
- Actively contribute as a member of the Quality
Assurance/Quality Control teamA successful Quality Control
Associate will have:
- Must have the ability to manage multiple priorities/projects,
resolve issues, and work in a fast-paced and flexible
environment
- Must possess confidence and be able to communicate with all
levels of personnel
- Must be able to work with external laboratory and manufacturing
partners
- Strong understanding of data analysis tools and root cause
analysis
- Strong oral and written communication skills with the ability
to articulate technical information in a clear and concise way
- Commitment to fostering an inclusive environment across the
organizationTo be considered for the position, you must have:
- Bachelor's degree in Life Sciences
- 1+ years' experience working in a GMP laboratory and/or
stability program management
- Understanding of Current Good Manufacturing Practices (CGMPs),
United States Food & Drug Administration (FDA) and International
Council for Harmonisation (ICH) guidance documents related to
Stability and data integrityAdditional preferred qualifications:
- Experience with electronic quality systems for documentation
and processes (e.g., MasterControl) preferred
- Bachelor's degree in Chemistry is preferred
Keywords: Kal--o, Richmond , Associate, Quality Control, Other , Richmond, Virginia
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