Job Description:Position Summary:|
This position is primarily responsible for product label
generation for medical products, Device History Record
inspections and receiving inspections. Position provides
support for the corporate QMS CAPA system, data entry
into the Training Database, transcription of minutes,
and creation and execution of quality system
Essential Duties and Responsibilities:Label Generation:
1. Prioritizes duties to ensure once order for label
printing is received it can be executed as soon as
possible and notifies inspectors and verifiers in order
to meet label requests thereby ensuring production
down-time is avoided.
2. Communicates label printing scheduling needs to
supervisor so reorganization of priorities are
understood and agreed.
3. Remains abreast of label regulations and changes to
those regulations through consultation with BTL
Regulatory staff to support evaluation of process
improvements in order to ensure compliance.
4. Recommends process improvements to Standard Operating
Procedures regarding label security, generation,
inspection, verification, and release activities;
originates DCO’s as needed to support process
5. Organizes and ensures label stock security after
transfer from the warehouse area and manages label stock
returns. Oversees label security for labels generated
for production orders until labels are released to
6. Analyzes and troubleshoots mechanical label printer
issues by consulting Maintenance and/or IS personnel and
consults with label printer vendors as needed.
7. Trains label generator backups and ensures process
modifications are communicated to trained backups.
8. Evaluates and recommends equipment improvements and
communicates increases from existing printing times to
management so equipment improvements or expansions can
9. May train personnel responsible for label processing
activities through coordination with interdepartmental
10. Provides backup support for label DCO issuance.
11. Upon request consults with clients regarding label
1. Executes receiving inspections for those inspection
plans in which QA involvement is determined as
2. Executes in-line inspections to support product
3. Assists in establishing receiving and in-process
inspection plans through DCO review and provides input
to ensure execution of inspection plan is attainable.
4. Utilizes inspection equipment such as calibrated
calipers and rulers or other equipment as needed.
5. Develops and provides recommendations of receiving
inspection equipment storage.
6. Evaluates and recommends improvements to the
receiving inspection process including space designated
within facility for execution of inspections.
7. Executes procedural requirements for DHR inspections.
8. Communicates and resolves issues found in the DHR
with relevant departments.
9. Communicates repetitive issues found to supervisor
and relevant department heads thus providing feedback so
process improvements are considered.
10. Ensures records in the DHR are in correct filing
order when inspection is complete.
items from initiation to final approval.
- Provides backup support or completes assigned QA Issue
1. Assists relevant department heads with documentation
of issues, and ensures clients are notified of issue
2. Ensures supporting documentation is attached and
electronically filed if applicable.
3. Maintains QA issue books and monitors checkout system
when issues are removed for completion or routing.
Backup Support for Active Records, Archive Record
Storage and the Training Database
1. Assists with filing hard copy records in the active
and the archival (mezzanine).
2. Provides backup support for electronic scanning,
storage, indexing and tracking of identified records,
and/or reviews the scans and subsequent electronic
archival of others.
3. Remains abreast of record retention policies required
by the company and required for regulatory compliance.
4. Fulfills file retrieval requests through use of
checkout system or provides copies of stored records.
5. Assists as requested in record rotation between the
manufacturing and QA storage areas.
6. Helps support the process of returning or destroying
client record copies and assist in maintaining records
recording this event.
7. Evaluates submitted training records to ensure the
records are complete and consults with originators as
8. Assists with accurately entering internal and
external training records and ensures those records are
available upon request from internal personnel or
9. Provides assistance to leads/supervisors regarding
training report and training record inquiries.
10. Assists with hard copy filing of training records.
Quality Assurance Support
1. Serves as support to complete and distribute meeting
2. Prepares charts and graphs for presentation in
Quality System meetings.
3. Aware of critical areas and equipment, and reports
issues to QA Supervisor and department head.
4. Conducts individual and group training on concepts,
processes, and policies.
5. Plans and executes special projects as requested.
6. Other responsibilities identified based on experience
printers, laptops, projectors, faxes, copy machines, and
- High School diploma or equivalent
- AA degree preferred
- Ability to use office equipment such as label
ability to identify and incorporate new equipment used
to support the primary areas of responsibility.
and ability to learn other label printing software.
- Intermediate ability level with MS Office software.
- Intermediate ability level with Label Vision software
- Familiarity with FDA and International Standards and
functional areas across internal and external
- Ability to work well with individuals in all
- Desire to deliver and ensure accuracy in all
grammar and spelling.
- Ability to read and proof read documents for correct
correspondence, meeting minutes and procedures.
- Ability to plan and conduct effective meetings.
- Strong organizational skills.
- Ability to assist in writing reports, business
and distinguish colors.
- Strong multi tasking, and prioritization skills
- Ability to work unsupervised.
- Ability to lift and exert force of up to 25 lbs.
- Color vision with the ability to accurately identify
Join Biotest Laboratories,
- Corrected vision to 20/20.
a STERIS Corporation company in its vision to see the
world free from
Infection and Contamination as a
QA Technician – Production Support
STERIS is a $1B+, publicly traded (NYSE) organization of
over 5000 employees and is dedicated to providing
innovative infection prevention, decontamination, and
health science technologies, products and services.
STERIS Corporation is an equal opportunity/affirmative
STERIS Corporation & Biotest Laboratories, Inc. complies
with all obligations with respect to online application
systems under guidelines provided by the US Department
of Labor's Office of Federal Contract Compliance
Programs. If you are a disabled person who requires
reasonable accommodation to complete an online
application, please contact Rebecca Hoppe by phone at
763-315-1200, for assistance.
STERIS Corporation (STERIS), together with its subsidiaries, develops, manufactures, and markets infection prevention, contamination...