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Job: Production Associate, CoImmune Inc., Durham, NC

General Information


Job title:
Production Associate
Job location:
Durham, NC  27704 United States
Requisition code:
Date posted:
05/13/2019
Compensation:
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description


The individual will conduct cGMP manufacuring of a cell-based product. This includes validation and devopment runs under cGMP and assistance in technology transfer of novel products. All activities will be performed in a cGMP-compliant environment.

RESPONSIBILITIES:
• Execute procedures to manufacture cell therapy products ensuring that production batch records are completed at the
highest standards according to Company policies and procedures.
• Assist with review and organization of completed batch records, address deviations and support investigations as
necessary.
• Perform daily clean room activities such as equipment/material preparation and cleaning/sanitization of equipment and
rooms.
• Assist in ordering and transfer of materials and maintain supplies adequate for production demands. Stocking of non lot
controlled materials and cleanroom garments.
• Assist with execution of environmental monitoring of air, surfacecs and personnel in classified areas.
• Provide assistance with authoring and revision of Batch records, SOPs, Temporary changes, Item Specifications and other
cGMP documentation.
• Collaborate with and assist other groups with projects by executing protocols assosiated with validation, technology
transfer, etc.
• Perform Biohazard waster packaging and disposal per established procedures
• Perform other duties assigned.

Job Requirements


QUALIFICATIONS:
• An associate degree with 2-3 years of relevant experience.
• Experience with cell culture and/or molecular biology and aeseptic techniques is strongly preferred.
• Hands on experience working in GMP clean room is preferred.
• Good communication skills to clearly convey complex information and ensure proactive communication in timely manner.
• Must have strong computer skills.
• Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other
groups.
• Must have initiative, high attention to detail, and the ability to multi-task
• Flexibility with work schedules and duties including necessary extended hours, weekends and holidays
• Ability and willingness to be regularly, predictably, and reliably at work

PHYSICAL DEMANDS:
Majority of work is sedentary with standing, sitting, and bending. Some occasional physical demands such as: pushing, pulling, and lifting up to 30 lbs. Good dexterity and balance required.

The requirements listed in this job description are representative of the management's assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn't constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.
(Job number: 3839036)
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