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1st Shift Quality Technician, Incoming / BPR Review na None

None · Huntsville, Estados Unidos Da América · Onsite

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Job Summary - a concise overview of the job

 

Quality Technician, Incoming Materials is responsible for performing procedures related to sampling, inspection of raw materials, packaging components, and issuance and inventory control of labeling to ensure conformance to specifications.  Manages labeling revisions and obsolescence according to directives. Participates in gap analysis and recommends and revises revisions to SOPs.  Initiates vendor complaints.

 

Quality Technician, Batch Record Review demonstrates competence in reviewing Batch Production Records (BPRs) to ensure compliance to procedural requirements.  Reviews BPRs with attention to detail in order to identify problems, errors or issues with the records.  Has solid working knowledge and skills in practices, procedures, and techniques in the Batch Record process.  Identifies deviations from procedures, tracks and provides BPR metric results as required.   Communicates to multiple departments and supervision to ensure timely correction of errors.  Identifies and escalates issues or problems to appropriate supervision.     Participates as a team member on cross-functional teams.  Participates in reviews and structured processes for continuous improvement.     Assists in trouble-shooting issues.     Trains entry-level BPR Technicians.     

 

Perform other duties as assigned

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Quality Technician, Incoming Materials is responsible for sampling, inspecting, issuance and inventory control of materials. Batch Record Review supports the TriRx business.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Sampling

 

 

 

 

 

 

 

 

 

 

Batch Record Review

  • Is competent in all applicable procedures & sampling SOPs
  • Is competent in and can perform two or more sampling processes (raw materials, components, and labeling material)
  • Performs cycle count, as needed (for labeling material only)
  • Coordinates with the warehouse to retrieve materials required for inspection and sampling
  • Samples materials & accurately completes associated documentation
  • Sends samples to the chemistry or micro lab for analysis
  • Cleans sampling rooms and equipment
  • §  Properly handles and submits material retains to the archive storage

 

 

  • Identifies complex errors such as calculation conversions
  • With demonstrated competence, reviews production records in a timely manner and resolves errors in collaboration with manufacturing personnel
  • Reconciles BR entries with other documentation/ procedures
  • Notifies supervision concerning errors that may need further investigation
  • May create release labels and place on product cartons; reconciles labels against quantities as needed 
  • Assists in inventory reconciliation for controlled substances
  • Has solid working knowledge of BPR process and expands technical skills related to BPR process

40%

Inspection & Metrics Analysis

  • Examines raw materials, components, and labeling materials to ensure conformance to specifications
  • Confirms material identity, content accuracy, and quantity through visual inspection against supplier/internally provided documentation and CoA
  • Performs and documents daily calibration checks of labeling equipment
  • Perform minor physical analyses per SOPs
  • Documents Batch Errors and provides error tracking to management.
  • Able to identify potential issues and trends and escalate to supervision.

30%

Labeling Material Issuance & Inventory

  • Counts & issues released labeling to Packaging
  • Counts & reconciles labels returned from Packaging
  • Prepares and applies release labels
  • Reconciles each labeling control number labeling
  • Maintains accurate records of inventory transactions.
  • Maintains inventory of labeling supplies

20%

Problem Solving 

& Training

  • Participates in resolving complex issues
  • Trains Quality Technician for Incoming Materials and Batch Record Review

10%

Compliance

  • Follows internal processes related to controlled substances
  • Initiates vendor complaints

continuous

Quality Issues

Responds to and escalates events

continuous

Continuous Improvement

  • Participates in gap analysis and recommends revisions to SOPs
  • Participates in process improvement initiatives

continuous

Safety

Follows EH&S procedures to ensure a safe work environment

continuous

 

Other duties as assigned

 

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • High School diploma or equivalent
  • A minimum of 3 years of relevant experience

  

Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Attention to detail
  • Strong documentation skills
  • Ability to read and interpret SOPs and function within the scope of procedures
  • Ability to follow complex processes
  • Ability to communicate and work with teams
  • Is knowledgeable of relevant cGMP regulations and processes

 



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