Quality Manager Job
Posted on: June 9, 2021
Reports directly to the Plant Manager and dotted line to
Regional Director of Manufacturing. Direct reports include 1 Lead
Lab technician and 4 Lab Technicians in Geneseo and dotted line
reports of QC leads for 4 Business unit sites in Texas,Virginia,
Mexico and Brazil.
Geneseo: Responsible for direct customer liaison as related to
the daily operation of the Quality Control Lab. Ensure efficient
management of all Quality Systems and AIMS program. Responsible for
developing and maintaining robustness in the quality system to
comply with ISO 9001 and AIMS guidelines. Responsible for the
maintenance of the analytical control of the lab methods and
corrections, specialized product testing and upkeep of analytical
BU: Leads the standardization efforts across the five America's
BU sites on quality related procedures, processes and forms related
to cGMP, ICH Q7, FDA guidelines, ISO 9000, AIMS elements and BU
specific standards. Examples of the later include customer
complaint handling, specifications, analytical techniques, etc.
Essentially, this role is the 'go-to' person for quality related
questions or issues in the BU in the Americas region.
- Responsible for management of Food Safety Management System
(FSMS), and serves as Preventive Controls Qualified Individual
(PCQI); manage and organize the work of the Food Safety Team (FST);
ensure relevant training and competencies for the FST; report to
top management on the effectiveness and suitability of the
- Maintain compliance and serve as representative for cGMP, ICH
Q7, FDA, Kosher and Halal requirements which includes the Drug
Master File, cGMP procedures and routine auditing related to the
pharmaceutical grade Benzoyl Peroxide (ICH Q7).
- Manage AIMS program; provide leadership and direction to
element champions and serve as primary contact for audits.
- Maintain ISO 9001 quality system certification and serve as
contact for all quality related audits; monitor the efficiency of
the quality system by performing internal audits at regular
- Lead the coordination and or investigation of all customer
- Install and maintain data in SAP and LIMS.
- Manage non-conforming product system.
- Ensure all laboratory facilities, instruments and inventory are
maintained in an efficient and safe manner.
- Directs supervision of lab techs; motivates team for high
- Maintain a system for monitoring regulatory requirements and
trends, including QA related issues within the industry.
- Coordinate special analytical requests of Operations,
Technical, R&D, sales and Marketing.
- Develop analytical and standard operating methodology as
- Ensures employees work safely by conducting safety inspections
and adhere to safety regulations and procedures.
- Train technicians in current laboratory procedures and
instrumentation as needed.
BU Regional (35%)
- Quality processes
- Responsibility and authority for reporting to top management,
Plant LT and / or BU LT, whichever is appropriate, on the
performance of the quality system and any need for
- Leads effort to collect ideas on how to continuously improve
quality of products and customer's perception of quality,
prioritizes, develops implementation plans and presents to BU LT
for approval of implementation.
Provides oversight and ensures BU awareness and compliance with
all processes / procedures affecting quality; e.g. new raw material
acceptance, new or changes to product specifications, customer
specific specification approval, etc.
- Interacts with Business Teams on quality related issues.
Connects with BU R&D & Central Analytical in KoP for input on
QC analytical procedures, instrumentation recommendations & input
- Forms and leads a multi-site quality network that aligns on
standardized quality processes and procedures via at least annual
face-to-face meetings and monthly conference calls.
Required Education/Qualifications/Work Experience:
- B.S/B.A. degree in Chemistry or related degree with 10+ years
of quality experience in manufacturing or equivalent and a minimum
of two years experience with quality aspects of Organic
- Demonstrated experience with FDA guidelines, including
excellent knowledge of Drug Master File (DMF)
- Knowledge of wet chemical techniques and fundamental
- Demonstrated experience in successful implementation of current
Good Manufacturing Practices (cGMP)
- Demonstrated experience in maintaining compliance with ISO 9001
certification and other relevant standards; Lead Auditor
- Knowledge of instrumental methods of analysis, including gas
chromatography, liquid chromatography, UV-visible spectroscopy,
infrared spectroscopy, atomic absorption spectroscopy
- Excellent communications and organizational skills.
- Excellent skills in MS Office; SAP preferred
Job Segment: ERP, Chemical Research, Law, Pharmaceutical Sales,
Quality, Technology, Engineering, Legal, Sales
Keywords: Arkema, Rochester , Quality Manager Job, Other , Geneseo, New York
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