Packaging Process Technician in Albuquerque, NM at AMRI

Date Posted: 8/12/2019

Job Snapshot

Job Description

Packaging Process Technician
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
Summary The Packaging Process Technician will provide quality oversight to the packaging processes and functions during the inspection and cartoning of commercial product lots.  Direct support and oversight will be provided to internal departments to ensure compliance of cGMP standards and FDA regulations.  Additionally, the Packaging Process Technician will perform real time review and approval of PBRs and supporting documentation accompanying the packaging processes and work with appropriate Line leads/Supervisors to ensure documentation errors or issues are resolved.  The Packaging Process Technician will be responsible for the inspection of finished product lots including labeling and cartoning operations.  Additionally, the Packaging Process Technician will perform incoming inspection of labeling and production components and will assist in sampling and release of API and Excipients.
The Packaging Process Technician will provide direct support for the MQA SR. Manager to investigate, troubleshoot and resolve packaging or inspection issues.  Additional inspections on validation lots, samples, media and/or water runs will be performed by the Packaging Process Technician when required.  The Packaging Process Technician will pull and inspect additional samples and retains. 
Essential Duties and Responsibilities:
  • Perform online AQL inspections on Finished Product.
  • Perform online AQL inspections on Labeling and Cartoning of Finished Product.
  • Perform incoming inspection of Production components including but not limited to vials, stoppers, seals and filters.
  • Perform incoming inspection of Packaging components including but not limited to labels, cartons, inserts, syringes, needles and alcohol pads.
  • Perform line clearances for Packaging and Inspection lines and grant approval for proceeding with lot inspection and/or labeling and cartoning.
  • Generate, verify and print In-House labeling components.
  • Issue components to the Packaging department.
  • Perform Return to Stock of Packaging components.
  • Perform Chemical sampling and assist in Excipient and API release.
  • Review all sections of Packaging Batch Records (PBRs) for correctness and troubleshoot issues real time. 
  • Review of Packaging Batch Records will entail process and documentation analysis and approval for each area of the processes including inspection, labeling, cartoning, reject and final product counts. 
  • Monitor building 4401 for temperature, pressure and humidity using the Environmental Monitoring System.
  • Perform annual inspection of retains.
  • Pull and inspect retain and customer samples.
  • Destroy Rejected materials
  • Enter information and steps as applicable in the JD Edwards inventory system.
  • Provide oversight to ensure cGMP compliance is followed throughout inspection and packaging processes. 
  • Work closely with MQA Shift Manager to ensure timely completion of projects.
  • Assist in coordinating functions of internal QA organization with customer and internal departments. 
  • Ensure timely notification of issues to both the Customer and appropriate Management personnel.  Initiate and perform Trackwise® investigations as they relate to the packaging processes. 
  • Provide other necessary QA support as designated by Management.
  • Required to modify shift if directed by management to cover needs of both the QA and operations organizations.  May be asked to split shift or rotate to cover night shift as required to meet the team’s goals.
Supervisory Responsibilities:
This job has no supervisory responsibilities

Job Requirements

Education and/or Experience:
High school diploma or general education degree (GED); and three months related experience and/or training; or equivalent combination of education and experience.
Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization
Mathematical Skills:                                               
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.
Computer Skills:
To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.                           
Other Skills and Abilities:                                                  
Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, MOH and FDA.  Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations, Chapter 21, Part 11 and Sample Distribution per PDMA Prescription Drug Marketing Act.  Provides leadership in coordinating audits and services as the resident QA product expert at site and among departmental staff.  Must have demonstrated ability to work independently and as a team leader.  Must show innovative development techniques and strategic thinking abilities.
Other Qualifications:
Must pass background check
Must pass drug screen
 
Physical Demands:
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; 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, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Shift:  

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.