Quality Assurance Supervisor - Operations
Company: NorthStar Medical Radioisotopes, LLC
Posted on: November 11, 2019
Applicants must be able to work legally within the United States,
and we currently do not offer H1B Visa sponsorship. Please, no 3rd
SUMMARYThe Quality Assurance (QA) Supervisor - Operations is
responsible for providing oversight for Operations/Manufacturing to
ensure day to day compliance with applicable domestic and
international regulations and standards so that product
distribution to the desired markets is realized. The QA Supervisor
- Operations will be responsible for ensuring that cGMP compliant
quality processes are maintained.
ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following, other
duties may be assigned:
- Direct and assist with the daily QA functions by maintaining
internal QA and site systems to meet site needs while ensuring
adherence to Good Manufacturing Practice (GMP), Good Laboratory
Practice (GLP), Good Documentation Practice (GDP), and other
- Direct and perform the review of documentation including but
not limited to Procedures, Batch Production Records, Equipment
Qualifications Protocols, Analytical Method Validation, Process
Validation Protocols, and Nonconformity investigations related to
materials, process, and products.
- Assist in the development of QA plans by identifying critical
control points and preventive measures, monitoring adherence to
procedures, and implementing corrective actions and verification
- Initiate, review, and approve change controls.
- Assist with regulatory audits.
- Ensure quality metrics are collected, reviewed, and actionable.
Prepare quality documentation and reports by collecting, analyzing,
and summarizing information and trends including production
processes, environmental monitoring data, CAPA, Nonconformance, OOS
data, and validation information. Report quality metrics to Senior
Manager, Quality Assurance - Operations.
- Perform Internal Audits, External Audits, and Data Audits, as
assigned by Senior Manager, Quality Assurance - operations.
- Support the resolution of product/assembly issues in
Operations/Manufacturing through coordination of quality system
investigations, recommending customer bulletins, etc.
- Provide on-the-floor QA oversight of manufacturing
- Assist in document creation and review, including Standard
Operating Procedures, protocols, batch production records, and
- Ensure direct reports remain current on their required
- Perform other quality assurance functions as necessary, with
- Effectively communicate safety and quality issues raised by
customers or staff in a timely manner.
- Support NorthStar's Quality System and Health & Safety Program
by following policies and procedures.
Ability and willingness to travel, both domestically and
internationally, up to 20% of the time.
QUALIFICATIONSTo perform this job successfully, an individual must
be able to perform each essential duty satisfactorily. The
requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
EDUCATION and/or EXPERIENCEBachelor's Degree in Chemistry, Biology,
Engineering or other related scientific discipline and five or more
years of Quality Assurance experience within the
pharmaceutical/medical device; or equivalent combination of
education and experience. A minimum of two years of lead experience
over Quality Professionals is required. Experience working directly
with regulatory agencies, sound knowledge of applicable portions of
agency guidance's, and regulations (21CFR Part 210/211/820).
Experience with radiopharmaceuticals preferred.
COMPUTER SKILLSProficient knowledge of Microsoft Office software
programs, including Outlook, Word, Excel, and PowerPoint.
SUPERVISORY RESPONSIBILITIESInterview, hire, and train employees;
plan, assign, and direct work; appraise performance; reward and
discipline employees; address complaints and resolve problems.
- Ability to work long (> 8 hours) and unusual hours to
include weekends and holidays
- Basic knowledge of analytical, microbiology, and stability
- Strong attention to detail
- Excellent communication skills, verbal and written
- Ability to work in a team environment, as well as
- Ability to handle multiple projects simultaneously
- Ability to work in a fast-paced environment
- Adaptable to change in the work environment
- Experience with Process Validation - writing protocol,
reviewing protocol, executing protocol
- Ability to read and interpret engineering Drawings
- Knowledgeable in Auditing. Auditing Certification
- Knowledgeable in Statistical Applications
Keywords: NorthStar Medical Radioisotopes, LLC, Janesville , Quality Assurance Supervisor - Operations, Other , Janesville, Wisconsin
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