Manufacturing Supervisor in East Windsor, NJ at Integrated Resources, Inc

Date Posted: 5/8/2021

Job Snapshot

Job Description


Job Overview:

Manufacturing Supervisor should have:
Ability to work effectively with in a team environment with key functional groups.
Ability to handle and manage clean (Classified) rooms and their operations.
Ability to take ownership to meet company goals/ needs and perform under pressure.
Leadership and motivate skills, with strong work ethic, integrity, and stability in the workplace and ability to work in a fasted paced environment.
Able to communicate/ coordinate effectively with departmental staff and be able to follow instructions both written and verbal.
The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions.
A continuous improvement and quality mindset. A willingness to develop self and others.
Ability to investigate issues, analyze root causes and define resolutions. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, FDA regulations and/or MSDS.


DUTIES & ESSENTIAL JOB FUNCTIONS
PERCENT OF TIME
(Time of all duties must add up to 100%)
FREQUENCY
(daily, weekly, monthly, quarterly, yearly)
ESSENTIAL DUTIES (List in order of importance most significant first)
80%
Daily
To ensure that manufacturing activities being performed as per approved procedure and co-ordinate with concerns departments to execute the work as per schedule.
20%
Daily
To train and monitor Manufacturing employees.

Responsibilities:

It is the Manufacturing Supervisor s responsibility:
To ensure that the production equipment used for Manufacturing are clean and set up properly and the equipment are in calibrated state before the use of production.
To work proactively in addressing potential issues and applies real-time problem-solving skills when working towards resolution. Responsible for the development and implementation of manufacturing processes and equipment to maintain proper product functionality as well as cost efficiency and resource allocation.
To Identify existing and potential operational problems and inefficiencies and work towards /recommend resolutions. Takes an active role in identifying training needs, challenging and developing both direct and indirect reports in their positions for future opportunities.
To ensure the adherence of company policies, cGMP s and Standard Operating Procedures or any other regulatory requirements.
To make available of IQ, OQ and PQ protocol, Batch records, SOPs, and clean room practices and review and update periodically to ensure that the Manufacturing facilities and equipments are fully compliant.
To perform all additional tasks relating to the operation of the manufacturing department as requested / assigned by management.
To takes an active leadership role in development and implementation of continuous process improvement tools in assigned department(s).
To ensure that the qualification and validation of Area such as AHU & LAF and equipments such as Isolator, steam sterilizer, washing machine, tunnel, filling machine, Lyophilizer and other equipments, utilities and facilities should be performed as per schedule by following the safety, regulatory and cGMP norms. Documentation such as Change control, deviation, risk analysis, CAPA etc.

Qualifications - Skills & Requirements:

The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems.
The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions.
The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
The ability to maintain an attention to detail while executing multiple tasks.
The ability to exhibit flexible thinking.
A continuous improvement and quality mindset.
A willingness to develop yourself and others.
Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS.
  • BS e.g. Bachelor of Pharmacy or related.
  • Up to 5 years of work experience in a pharmaceutical manufacturing environment.