Quality Assurance Manager
Company: Akron Bio
Location: Boca Raton
Posted on: August 7, 2022
Job Description:
Akron Biotech is continuing to transform and further its rapidly
growing capabilities and is now seeking highly motivated scientific
professionals to join our rapidly expanding team. This role is an
exciting opportunity to play a critical scientific role within our
organization that is accelerating the biotech industry's
capabilities through the development and cGMP-compliant solutions
to support the development and commercialization of advanced
therapies. We manufacture and distribute components and raw
materials for cell therapy discovery, development, and
commercialization to meet industry needs worldwide. We offer highly
competitive benefits and perks to our highly valued associates. -
Summary Develops, implements and manages a Quality Assurance
Program and a Quality Management System which is consistent with
all applicable and current FDA, CFR GMP, GLP, ISO-9001 and
standards. -General Responsibilities
- Responsible for the development, implementation and maintenance
of the Quality Management System (QMS) and periodically provides
reports on the performance of the QMS along with recommendations
for improvement.
- Develops and maintains a current Quality Manual System Manual
and current Standard Operating Procedures (SOPs), guidelines,
standards and records.
- Responsible for controlling new and revised documents required
for the operation of the QMS pursuant to the Quality Management
System Manual. Please see Manual for detailed outline of
responsibilities.
- Establishes quality standards and policies, performs needed
organizational assessments and manages projects in support of
organizational goals and strategic objectives.
- Maintains a robust Quality Assurance Program which addresses
batch disposition, deviation, investigation and corrective action.
- Develops staff and drives new approaches to Quality Assurance
and Quality Management principles, theories, concepts and
techniques.
- Develops a system for management of technical product
complaints.
- Reviews and approves -SOPs, protocols, reports, and production
batch records
- Leads and manages the day to day activities of all quality
assurance personnel and ensures the efficiency and effectiveness of
all on-site quality system activities. Provides quality "on the
floor" support for all Operations
- Manages and coordinates all aspects of the lot review process.
Ensures timely disposition of final drug product lots
- Manages Quality Review Board activities, Corrective and
Preventive Action System, Document Review/Traceability Release
function, Final Product Disposition, and Labels
- Represents Quality Assurance on cross-functional teams
participating in various operational programs such as FMEA
development, Risk Management activities, Master Validation
Planning, LEAN improvements, and other continuous improvement
activities
- Reviews and Approves deviations / non-conformances. Establishes
effective corrective action plans of all the Operations department
non-conformances. Drive towards timely closure and effectiveness
- Leads, supports, and participates with the Operations functions
to proactively investigate, identify, and implement best-in-class
quality manufacturing practices
- Formulates and maintains quality assurance objectives
complementary to corporate policies and goals
- Manages QA personnel to meet QA objectives. Designs and
implements Quality Assurance training programs for key relevant
personnel
- Ensures compliance with the Quality System Regulations, cGMP
and industry standards
- Writes/revises quality procedures or Work Instructions or other
department operating procedures
- Provides support to audits and regulatory inspections and
ensures the execution of corrective action and compliance with
internal quality procedures and external standards
- Manages the document control function
- Conducts investigations and internal audits of procedures,
forms and all associated documents consistent with cGMP, cGLP and
EHS practices and guidelines.
- Generates audit reports, opportunities for improvement and
other QA documents as required.
- Initiates CAR's or PAR's as needed.
- Oversees the CAPA Corrective and Preventive Action Program.
- Provides feedback and advice related to Customer Complaints.
- Hosts internal regulatory and accrediting agency compliance
inspections and audits.
- Prepares responses to regulatory and accrediting agency
compliance inspection and audit reports.
- Conducts compliance inspections and audits of contract
manufacturers and vendors/suppliers of products utilized by Akron
Biotechnology.
- Prepare reports of investigations or audits findings of
contract manufacturers and vendors/suppliers.
- Conduct s internal investigations and audits and provides
reports of investigation or audit findings to appropriate entities.
- Establishes and conducts a training program for employees on
all pertinent SOPs, industry regulations and standards.
- Conducts Environmental, Health & Safety (EHS) training for
employees engaged in handling biological products or potentially
bio-hazardous materials.
- Conducts cGMP and cGLP training, as needed.
- Evaluates employee competence and issues training certificates
as applicable.
- Oversees laboratories' production schedule.
- Interacts with Shipping and Receiving, Operations Director and
other internal groups to facilitate order processing and
fulfillment.
- Participates in Management Reviews.
- Exercises sound judgment in addressing and proactively managing
business issues with minimal direction and supervision.
- Performs other duties as assigned. Requirements
- BS in Biology or life science field highly preferred.
- 3-5 years of life science related Quality Assurance experience
is required; experience functioning as a Senior Associate or
Manager is required.
- Knowledge of FDA, CFR, GMP, ISO-9001 regulations and standards.
- Minimum of 7 years working in the biopharmaceutical, cellular
therapy, or gene therapy industries
- Direct experience supporting the manufacturing, testing,
disposition, and distribution of cGMP products in the Manufacturing
or Quality organizations. Prior supervisory experience required
- Experience in the implementation and execution of Quality
Systems
- Excellent communication, trouble shooting, and problem solving
skills
- Strong team player that can also work independently to achieve
objectives
- Must be highly motivated and able to work independently while
maintaining open communication with supervisor, staff and others
within the Company.
- Demonstrated ability to work collaboratively with employees in
other cross functional groups using a proactive approach to problem
solving.
- Able to think strategically and participate in business
planning meetings.
- Possesses the judgment level needed to execute plans and
accomplish goals.
- Shows a high degree of initiative and is resourceful and
results oriented.
- Energetic team player with strong organizational, analytical
and problem-solving skills with a fundamental knowledge of
marketing concepts, practices and procedures.
- Superior interpersonal and team building skills.
- Superior verbal communication and presentation skills.
- Superior English writing skills and is able to clearly convey
ideas in writing.
- Possesses outstanding technical writing skills and is capable
of generating SOP's, protocols, policies and a variety of technical
documents and reports.
- Possesses knowledge of Quality Management techniques.
- Ability to meet important deadlines.
- Strong computer skills are required - knowledge of advanced
software functions such as MS Word, Excel and Power Point an
ability to work well with Internet Explorer and Outlook.
Keywords: Akron Bio, Boca Raton , Quality Assurance Manager, Executive , Boca Raton, Florida
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