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Quality - Pharma - Lawrence, United States - MRINetwork Jobs
Description
Job DescriptionJob Description Our client – a growing company with multiple plants in the US, needs a
Manager
of Quality
at their plant expanding to manufacture
pharmaceutical products . Excellent salary up to
$120K
vacation. Job Posting # 2642
Job Title :
Manager Quality - Pharma
Location:
Lawrence, KS
Compensation:
Salary of
$100K - $120K
per year
Relocation:
YES
401K
3 Weeks'
Vacation 13 days
with
300 people
at manufacturing sites in
CA, KS
Group Info:
Be part of the medical device and pharmaceutical contract manufacturing site with around
100employees
and expected to grow to
150 people
soon due to major expansion in
Pharma manufacturing .
The
new operation expansion
is for Pharma -
Blow
Fill Cap – BFC
of
Sterile Solutions. The Quality group has around
25 people
from QC, QA, Quality, Validation, Compliance. This role will report to the
Director of Quality .This
Manager
will have a total of
14 people .
3 direct reports Quality Supervisor and
10 quality inspectors
under this supervisor for incoming, in process and final products inspections.
Job Summary:
The QA Manager is responsible for providing comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable Health Authori
Supports the manufacturing, testing, disposition, and distribution of all materials that company manufactur
Ensures product(s) consistently meets our customer and regulatory requirem
Responsible for the overall development, implementation, maintenance, and performance of the quality system.
Works with other departments to ensure progress toward company goals while maintaining compliance with QSR requirem Monitors quality processes and collects metrics to document performance.
Additionally, this position will drive day to day QA requirements for site readiness, the role will be involved in positioning projects with customers during the Business Development process as well as being involved in the actual project delivery ensuring that quality requirements are met as required by regulators and customerJob Description:
Establishes, implements, and maintains quality management system.
Ensures current quality management policy is in compliance with relevant regulatory agencies following laboratory protocol and procedu
Liaison between Manufacturing and QA for executed Batch Record Review and flow of docum
Reviews and dispositions production batch records for product releas Determines if records are compliant with internal and cGMP regulations.
Reviews and approves GMP product lab
Supports FDA/Regulatory inspection activities.
Supports regulatory filing as need
Collects and presents metrics to document performan
Train staff as needed.
Collaborates with other departments to address issues and meet deadlines.
Participates in and/or lead project teams as a Quality representative.
Provides support for internal and external audits.
Influence and implement initiatives within QA to improve overall compliance and maintain inspection readiness.
Develop, review, and approve
protocols/strategies
(validation, qualification, commission, et)
Ensuring that the QA department is integrated in project delivery from project initiation to completion.
Due to the nature of the development process and drugs/medical devices - the company environment is fast paced and constantly changing.
The individual will need to have the ability to ensure that prioritizing, allocating and monitoring work across team members to meet customer deadlines is managed appropriately.
Achieve throughput and turnaround targets on a project, monthly and annual basis, monitoring and reporting on the productivity of the team.
Report performance against Key Performance Indicators (KPIs).Develop a collaborative, pragmatic culture that encourages colleagues to support each other in problem solving to achieve excellent and timely results for custom
Candidate Must Have :
Bachelor's Degree
Min. 6 years
of
Quality
experience in
FDA
regulated Pharma or Medical Devices
Min. 3 years
of
Quality Management
experience
Excellent people, communication and management skills
to create a team environment
Good leadership skills
to motivate plant personnel and gain their respect
Working knowledge of
21 CFR Parts 210, 211 and 820
FDA
complian
Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.
Technical knowledge of
pharmaceutical manufacturing , validation, raw materials, analytical testing, and materials management is desirable.
Able to work effectively in a
customer service and business partner
rol
Candidate Nice to Have:
Technical degree in Science, Chemistry, Biology, Microbiology or Engineering
Certified Quality Auditor
certification, or equivalent.
Experience with remediation of
Quality systems
in
FDA483, warning letter, or Consent Decree .
Audit or inspection experience preferred.
Startup or Small company experience working in a
dynamic and hands-on
role.
Familiarity with Microsoft Project and project management principles.
Knowledge of
Sterile Aseptic Filling Operations
Contract Manufacturing
experience working closely with
customers and clients
Keywords:
BioPharma, Pharma, Quality, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant
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