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ByHeart
Allerton, IA | Full Time
$51k-66k (estimate)
2 Months Ago
Releasing Services Specialist
ByHeart Allerton, IA
$51k-66k (estimate)
Full Time | Pharmaceutical 2 Months Ago
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ByHeart is Hiring a Releasing Services Specialist Near Allerton, IA

The Releasing Specialist is responsible for managing Master Batch Records, Ingredient Release, and coordination of sampling, test data and related lab submissions. This role is a hands-on, highly interactive role in a fast paced, ever changing production environment. The individual must seek to drive continuous improvement of all aspects of the food safety and quality system.

Reports To: Director of Quality

Location: Allerton, IA

Start Date: ASAP

Role Responsibilities 

  • Responsible for managing incoming ingredients and packaging materials for compliance to specifications. Assist with raw material sampling, working closely with Logistics and Quality Laboratory. Submission of samples for testing per protocols to associated Laboratories, as required. Release of ingredients and packaging materials in Deacom the ERP system. Assist with physical release of materials per procedure.
  • Ensure customer guidelines for in-house and external lab testing is followed. Coordinate external lab testing and review of results to ensure it meets internal, customer, or regulatory requirements.
  • Preliminary review of laboratory analysis paperwork, laboratory records, production paperwork including but not limited to Master Batch records, sanitation records and pre-op records.
  • Complete initial review of Master Batch Records for completeness and elevate any Event Reporting, discrepancies, or Out of Specification (OOS) to the Quality Operations Manager.
  • Assist with the release or Quality hold of bulk in process product physically and or in the ERP system.
  • Assist with Creation of Certificate of Analysis for customers as designated by customer guidelines or internal requirements.
  • Organize and file Master batch records for the site, all related Contract manufacturing / packaging locations, ingredients, and customer related products.
  • Assist in completing documentation including but not limited to: Event Reporting, Corrective Actions, Change controls, Hold Reports, SOP’s, and forms that meet Internal and Infant Formula Requirements.
  • Provides written reports such as trending and aids in Event Reporting as required. Handwriting must be clearly legible.
  • Follows all laboratory and plant GMP and safety procedures according to company guidelines.
  • Performs all duties as assigned.
  • Complies with all policies and procedures of ByHeart.

Skills & Qualifications

To perform this job successfully, an individual must be able to perform each essential duty independently and satisfactorily. Performance will be evaluated on an annual basis. It is essential that responsibilities are performed correctly and accurately. Duties must be executed in a timely manner. Failure to complete tasks correctly and or on time may result in disciplinary action. The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Bachelor's degree required in Food Science, Biological Sciences, or related field.
  • 2-5 years of experience in food processing or pharmaceutical environment (Dairy, spray drying, or Infant Formula preferred)
  • Working knowledge of HACCP, Preventive Controls and SQF principles
  • HACCP and PCQI certifications are a plus
  • Familiarity with Laboratory testing and reporting preferred
  • Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form
  • Must be able to work independently – to organize tasks and manage the workload
  • Ability to deal with problems involving several variables in standardized situations
  • Must be able to do mathematical calculations
  • Must be able to elicit and or delegate help as needed
  • Effectively communicates critical information regarding job responsibilities
  • After completion of training, must be able to perform all relevant procedures accurately, precisely, and efficiently
  • Must be able to work on their feet for extended periods of time
  • Hours as needed by the company
  • The facility may be required to operate on all shifts and weekend/holiday hours due to the variable nature of our business
  • Must be able to lift up to 50 pounds routinely and navigate stairs safely
  • Use of computer systems including but not limited to ERP System (Deacom), Microsoft Word, Microsoft Excel, PowerPoint, and Doc Control System (Intelex)

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$51k-66k (estimate)

POST DATE

03/29/2024

EXPIRATION DATE

05/28/2024

WEBSITE

byheart.com

HEADQUARTERS

NEW YORK, NY

SIZE

25 - 50

FOUNDED

2016

TYPE

Private

CEO

CHRISTINE CASSIANO

REVENUE

<$5M

INDUSTRY

Pharmaceutical

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About ByHeart

ByHeart is a New York-based infant nutrition company that researches and develops immune, microbiome, cognitive and digestive health products.

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