Cleaning Validation Associate
Company: Renaissance LLC
Location: Lakewood
Posted on: September 17, 2024
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Job Description:
Renaissance LLC
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
Cleaning Validation Associate
US-NJ-Lakewood
Job ID: 2024-2774
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Lakewood, NJ
Overview
This Cleaning Validation Associate will support the Cleaning
Validation program, including equipment processes and procedures
for commercial and new R&D drug development activities at the
Lakewood, NJ plant. The role involves assisting in the generation,
review, and approval of protocols, deviations, and reports;
scheduling manpower activities; and providing feedback to both
internal and external customers.
The associate will help manage Cleaning Validation activities,
including Development, Verifications, Validations, and Monitoring,
under the guidance of a senior specialist. Regular interaction with
regulatory and compliance personnel is expected to ensure adherence
to FDA and international regulations. The associate will also
assist in representing Renaissance to customers and senior
management, contributing to the overall compliance and quality of
our validation efforts.
Responsibilities
1) Technical Support: Assist in understanding and applying the
principles of Cleaning Validation for development, verification,
validation, and monitoring.
2) Data Analysis: Support the development of Design of Experiments
(DOEs) and statistical sampling plans. Perform basic statistical
analysis and assist in evaluating data to support technical
decisions.
3) Batch Records: Help review Master Batch Records to ensure they
align with the validated state of cleaning processes and support
manufacturing schedules.
4) Validation Activities: Perform cleaning validation tasks (such
as sampling) within a pharmaceutical environment, ensuring
adherence to aseptic and sanitary conditions.
5) Regulatory Compliance: Implement and follow applicable
regulatory requirements, including FDA, ISO, and EMA guidelines, to
ensure compliance.
6) Resource Management: Assist in scheduling and planning resources
to support cleaning validation efforts and meet project
timelines.
7) Team Communication: Communicate expectations and updates to the
Cleaning Validation team. Assist in reporting team progress and
priorities to Validation management.
8) Customer Interaction: Support interactions with customers
regarding transfer discussions, timelines, and project
deliverables.
9) Time Management: Manage personal tasks effectively and assist in
maintaining team timelines. Report on project status and team
performance to cross-functional teams and site leadership.
10) Program Planning: Contribute to the generation and maintenance
of site program plans and the validation master plan.
11) Root Cause Analysis: Collaborate with area owners to identify
potential root causes and recommend preventive and corrective
actions.
12) Regulatory Discussions: Assist in discussions with regulatory
agencies, quality assurance, or clients as needed.
13) Process Review: Support the review of SOPs and internal
processes to ensure they comply with quality standards and cGMP
regulations.
14) Compliance and Improvement: Identify potential compliance
issues and areas for improvement.
Qualifications
Bachelor of Science degree in a Science, Engineering or other
related field required. Advanced education is preferred.Additional
education in project or documented investigational course work and
experience with cGMP software such as Trackwise preferred but not
necessary.Familiarity with current industry practices and
guidelines including those required / outlined by the FDA, ISO, EU
and ICH.
Compensation details: 68200-81000 Yearly Salary
PIf6ec7b56b0f0-37248-35395725
Keywords: Renaissance LLC, Lakewood , Cleaning Validation Associate, Other , Lakewood, New Jersey
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