Quality Control Supervisor
Company: ANI Pharmaceuticals, Inc.
Posted on: May 27, 2023
Position Summary This position is responsible for managing and
directing, a professional group of analysts engaged in physical and
chemical testing of raw materials, packaging components, in-process
materials, and finished drug products to determine conformance with
specifications. - This position is responsible for day to day
scheduling of analyst responsibilities to ensure production needs
are being met and that the laboratory is in conformance with cGMPs.
- Additional responsibilities include conducting and writing
laboratory investigations, notifying Quality Assurance of potential
product quality issues, coordinating contract lab testing, revising
SOP's, IOP's and other laboratory related documents. - Lastly, this
individual enforces company policies and directives that apply to
the department. - - Position Accountabilities
- 30% - - - - Manage and direct a group of analysts effectively
so company goals and objectives are met, provide input on resources
availability and needs to support production and project
plans/sales goals, and coordinates work schedules with other
departments. - Develops plans and timelines to assure analytical
support. - Assures effective and efficient utilization of
resources. - Establishes work priorities and expectations. -
Delegates authority and responsibility for the accomplishment of
planned work. - Provides direction and feedback for timely work
accomplishment. - Manages external laboratory resources to handle
overflow laboratory support.
- 25% - - - - Provides training and enforces policies and
procedures. - Assures systems and procedures are adequate by
developing, reviewing, and approving procedures to assure
compliance with governing regulations, filed applications, and
quality standards. - Identifies deficiencies and implements
corrective actions. - Provides technical expertise to support
investigations, protocols and procedures outside the laboratory. -
Monitors training, performance and development of professional
staff and provides feedback.
- 25% - - - - Performs reviews of data collected under approved
test methods, investigational plans, and protocols in accordance
with governing SOP's. - Approves all analytical data and results
and releases to Quality Assurance.Work with analysts to correct
deficiencies, mentor to assure understanding.
- 20% - - - - Notifies Quality Assurance in the event of a
potential product quality issues and conducts and writes laboratory
investigations. - Ensures timely implementation and closures of
CAPAs. - - Job Specifications - - - - Core Competencies
- Continuous Learning
- Customer Service Orientation
- Decision Making
- Strategic Thinking - - - - - -Functional Competencies
- Coaching, Consulting and Developing Others
- Data Affinity
- Project and Process Management
- Quality Standards and Best Practices - - - - - - -Minimum
- Bachelor's Degree in Chemistry, Microbiology, or related
- Education, training, or certification in Management and
Leadership - - - - - - -Minimum Experience
- 1 year experience in a leadership role in an analytical
laboratory in the pharmaceutical industry.
- 4 years of -experience in an FDA regulated laboratory in the
pharmaceutical industry RELOCATION TO BAUDETTE, MINESOTA AT TIME OF
HIRE IS REQUIRED - - - - - - - -Minimum Field-of-Expertise
- Ability to follow, prepare and explain technical matters and
- Ability to make decisions independently after appropriate input
from areas that will be affected.
- Ability to manage multiple projects and competing
- Ability to perform under stressful situations
- Demonstrated expertise of Laboratory cGMPs
- Excellent leadership, communication, and interpersonal skills.
- - - - - - -Preferred Education
- Advanced education in Management or Business
- Post graduate degree in Analytical Chemistry, or other relevant
area. - - - - - - -Preferred Experience
- 3+ years within the Baudette QC Organization.
- 5 years ofexperience in an analytical laboratory in the
Keywords: ANI Pharmaceuticals, Inc., Fargo , Quality Control Supervisor, Other , Baudette, North Dakota
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