We are seeking a QA Batch Record Coordinator to join our Quality Assurance team.  This individual works with QA management and personnel to ensure quality product throughout production. 
In addition, maintains all deviations, NRC files, retain samples and assists the Manager with the department activities and department workflow.


RESPONSIBILITIES:
  • Review manufacturing and packaging batch records.
  • Release of manufacturing and packaging batch records.
  • Provide batch record assessment for customer complaints/audits.
  • Release and issuance of labels and packaging components as necessary.
  • Communicate any errors to respective departments and the QA Manager.
  • Manage the storage and location of all batch records.
  • Manage, review all deviations of non-conformance reports and communicate any issues with the department managers.
  • Assists with the generation of labels for the Production department.
  • Prepares/collects samples from production and packaging for QC analysis.
  • Manage all Quality Assurance retain samples and batch records.
  • Solve/troubleshoot problems as required, implement changes to maximize Quality Assurance yields and efficiencies.
  • Generate reports to analyze the productivity of the department.
  • Report all areas of improvement needed for batch record efficiency.

EDUCATION:
 
  • Minimum High School graduated and/or equivalent combination of education and experience.
  • AA degree preferred.

QUALIFICATIONS:
  • 2+ years’ experience with minimum 1 year in an administrative role in the Pharmaceutical, Dietary, or a related industry prefer.
  • Knowledge of cGMPs and FDA regulations as it pertains to document control.
  • Self-starter with the ability to follow company and regulatory procedures, policies and guidelines
  • Ability to work independently and effectively in a fast paced, team based work environment
  • Ability to clearly communicate, both verbally and in writing, to all levels of the organization.

What We Offer: 

  • Competitive Wages
  • Medical & Dental (company pays 75% of employees HMO plans)
  • Discounted Vision
  • 401k match up to 3% of your salary
  • Life Insurance
  • Paid Holidays
  • Vacation Days
  • Sick Days
 
Robinson Pharma is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status with respect to recruitment, hiring, promotion and other terms and conditions of employment. Robinson Pharma takes affirmative action in support of this policy to employ and advance in employment individuals who are minorities, women, disabled, and veterans.

This is a non-management position
This is a full time position

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