Student or Entry-Level Job

Sr. Manufacturing Coordinator- 6636

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Simply Biotech
Posted: November 15 2016
Application Deadline: No Deadline
Position: Paid

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Description

Job Description

Sr. Manufacturing Coordinator- Simply Biotech

OVERVIEW

Immediate opening for a Sr. Manufacturing Coordinator in San Diego, CA who possesses:

  • Ability to read, write, and comprehend routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of the organization.
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  • Ability to deal with problems involving several concrete variables in standardized situations.
  • Technological proficiency for use of the personal computer, Microsoft Office Suite, and the Internet.

Email resumes to dwashburn@simplybiotech.com or call 858.381.4404

FULL DESCRIPTION:

Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking a Sr. Manufacturing Coordinator for a leading and growing biotech firm.

This position reports to the Senior Manager of Quality Assurance. The principal responsibilities include manufacturing/operations support, quality systems administration and development, and compliance. Additional responsibilities include providing back up support the QA lot release function.

The selected candidate will be responsible for the following:

  • Write manufacturing batch records for the following types of cGMP productions: manual and automated encapsulation, tableting, coating, fluid bed granulation, roller compaction, liquid fill/banding, spray dry dispersions, and more.
  • Collaborate with Pharmaceutics personnel and client with co-managing cGMP runs
  • Responsible for MFG protocols for secondary packaging and labeling activities
  • Host clients on-site / lead client meetings
  • Responsible for API specifications and clinical label specifications
  • Perform route cause analysis, address production issues and generate production variances
  • Generate CAPAs
  • Revise SOPs / streamline production batch records
  • Facilitate MFG tech transfer meetings with Process Development
  • Understand the work flow in the production suites
  • Provide troubleshooting support in MFG suites
  • Review executed batch records
  • Address product related-complaints
  • Other duties may be assigned

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel with fine dexterity, occasionally required to use a firm grasp; push/pull and talk or hear. The employee is frequently required to stand; walk; sit; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus (with corrective lenses, if needed).

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually quiet to moderate.

For immediate and confidential consideration, please email your resume to dwashburn@simplybiotech.com or call 858.381.4404

More information can be found at www.simplybiotech.com

Company Description
Simply Biotech specializes in recruiting exclusively for the biotech community.

How To Apply

Apply
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