Careers

Quality Assurance Associate

The Quality Assurance (QA) Associate will assist in the implementation, execution, and maintenance of Quality Systems to ensure Ash Stevens, Inc. (ASI) complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities.  Principle assignments related to compliance may include material release, review, and implementation of new and revised documentation to support ASI Quality Systems, internal and external audits, and training of ASI personnel to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both commercial manufacturing and process development in the Riverview facility.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Shall adhere to all safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Ash Stevens’ mission and values. 

KEY ACCOUNTABILITIES:

  • Review of batch production records (including analytical test packages, cleaning records, etc.: The incumbent’s primary responsibility will be to ensure that batches are manufactured according to approved Standard Operating Procedures (SOP), finished products meet specifications before releasing it to the client, and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations.  May facilitate the release of raw materials, intermediate products, and final Active Pharmaceutical Ingredient (API) based upon conformance with specifications and completion of associated documents.
  • Administrative Duties: Issue master production records to manufacturing, ensuring that the current version is issued.  File completed batch production records, testing records, and cleaning records.  Maintain change control files for master records, SOPs, and forms.  Ensure that current versions of the records are properly filed and available for use by the operations team.
  • Audits: Support audits of ASI Quality Systems and related operations to ensure compliance with written procedures.  Audits quality system and records, creating documentation as needed.  Follow-up as appropriate to ensure corrective action is implemented.  During an audit of ASI, may participate in the audit to explain ASI’s quality systems.  The incumbent is expected to represent ASI’s systems thoroughly and positively, being receptive to the auditor’s comments.  Participate in the development of a formal response to audit report as appropriate.
  • Reports: As required, participate in preparation of regulatory reports for the file or for submission to regulatory bodies.  This may include Annual Product Reviews, Non-Conforming Material Reports, and Deviation Investigation Reports.  Participate in preparation or review of associated documentation, such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.
  • Material Management Support: In conjunction with members of the Operations team, conduct a monthly review of materials inventory to assess inventory about to reach its outdate.  Remaining inventory will be moved into Quarantine status until an assessment is made as to disposition (requalification, consignment to waste, or transfer to non-GMP use).  In addition, when shipments of final API are made, verify labeling and packaging consistent with ASI’s SOP.
  • Training: Participate in training of ASI team members and in documentation and maintenance of training files.


EDUCATION/EXPERIENCE:

  • Bachelor’s degree in the physical or biological sciences.  Chemistry strongly preferred.
  • Minimum five (5) years of increasingly responsible experience in pharmaceutical operations, regulated life sciences, or quality assurance is preferred.
  • Knowledge of GMP requirements (21CFR Part 211 and/or ICH Q7).

 JOB COMPETENCIES:

  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
  • Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Physical demands:
    • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
    •  Long periods of sitting and walking may also be expected in this position. 
    • This position may require long periods of sitting, typing, computer entry or looking at a computer. 
  • Work environment:
    • Potential limited exposure to hazardous chemicals.
    • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Qualified candidates can submit their resume to careers@ashstevens.com
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Inventory Control Clerk

The Inventory Control Clerk is responsible to maintain inventory in several key areas (including production/plant and also maintenance and repair parts) and development and maintenance of a tool crib.  The incumbent will also function as support for shipping and receiving and dispense chemicals for scientists.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Shall adhere to all safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Ash Stevens’ mission and values.

KEY ACCOUNTABILITIES:

  • Inventory Management- Plant:
      • Maintain inventory levels of most commonly used materials, i.e. solvents, tubing, bottles, etc.
      • Enter order requests to restock (with input from Purchasing Manager).
      • Review listing of expired materials and ensure their transfer physically and in the system to the proper hold locations, along with updated labelling.
      • Ensure that materials in quarantine, hold, or approved are in their designated areas at all times.  Approval stickers will be applied when provided by QA and material moved to approved location.
      • Ensure acid/base, etc. designations are understood and are stored in proper locations.
      • Develop and deploy cycle count system for both GMP inventory and maintenance parts.
      • Dispense chemical products to scientists as needed. 
      • Responsible for both Epicor inventory and paper dispensing records.  When material is completely used up, ensure the system correctly reflects no inventory remaining and the paper dispensing record is closed with the variance calculations completely correctly and submitted to QA.
  • Inventory Management- Maintenance:
        • Develop and deploy inventory system for maintenance parts (spare parts for critical plant equipment, general spare parts, and general supplies). 
        • Maintain tool crib for special tools, one-of-a-kind pieces of equipment, ladders, extension cords, etc.  Keep tools is good working order; inspect for safety and functionality before issuing and once again upon return.
        • Maintain proper inventory levels for maintenance parts to ensure operational requirements are met.  Put in order requests to restock (with input from Facilities Manager).
        • Work with Facilities Manager to determine old/obsolete parts and items no longer needed.
  • Waste Management:
      • Work with outside vendor (Bentley) for removal of waste from site.
      • Prepare inventory of waste and sign manifests/paperwork as required when removed from site.
      • Shipping and Receiving:
        • Be the trained/certified backup for Shipping and Receiving.
        • Shipping- knowledge of FedEx website, types of shipments (including documents as well as large international shipments with specific shipping requirements). Knowledge of shipping requirements for hazardous materials and shipping with dry ice.
        • Receiving- must understand receiving requirements under GMP, storage, and labelling conditions.  Notify employees as appropriate of shipments received. 
  • Other:
    • Maintain various databases, as necessary, to support the plant.
    • Other duties as assigned, to meet the needs of the customer.

EDUCATION/EXPERIENCE:

 

  • Minimum high school diploma or equivalent.
  • One (1) year minimum experience in an industrial environment (chemical preferred).
  • Two (2) year’s verifiable experience driving an industrial power truck.

JOB COMPETENCIES:

  • Excellent organizational and record keeping skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Proficiency in computer applications (Microsoft Office, ERP systems, etc.).
  • Knowledge of regulations related to shipment of dangerous goods.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Physical demands:
    • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
    •  Long periods of sitting and walking may also be expected in this position. 
    • This position may require long periods of sitting, typing, computer entry or looking at a computer.
  • Work environment:
    • Potential limited exposure to hazardous chemicals.

Qualified candidates can submit their resume to careers@ashstevens.com