Environmental Monitoring Associate, Weekday Days

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The EM Associate is responsible for the monitoring of biological and airborne particulate levels in clean room environments for the purpose of preparation, compounding, and filling of sterile injectable drug products. The EM Associate will be trained on proper aseptic behavior, sanitization processes, and donning of sterile gowns.Associates will be required to have an aptitude for reading detailed procedures, clear documentation practices, and operating several environmental software applications; thus, computer understanding is highly encouraged for this position. Additionally, EM Associates will need dexterity to don sterile gowns, requiring a level of coordination to balance while ensuring garments do not touch floors while dressing. Additional responsibilities will include the collection of test samples aseptically, and preparation of tools, equipment, and supplies which will be used in a clean room setting.

Within the first Six (6) Months training requirements will include but are not limited to:

1. Collect product and environmental samples within an ISO 8 environment over extended periods of time (Typical EM shifts include 8, 10 and 12 hour days)
2. Operate appropriate monitoring sampling and testing equipment including associated software applications to compile data.
3. Prepare supplies required for collecting and testing of samples.
4. Operate Autoclave to prepare/sterilize supplies as needed.
5. Perform verification and incubation for EM samples.
6. Verify data for accuracy.
7. Read and understand SOP's as required. Maintain current SOP training requirements.
8. Obtain Aseptic Gown Certification

Six months (6) to Twelve (12) months:

1. Successful gown certification for ISO 7, 6, and 5 classifications, environmental monitoring and collecting test samples related to defined quality parameters for surface, air, personnel, product and utility systems such as compressed gas and WFI.
2. EM Associate must complete EM training in at least one of the major aseptic areas ISO 5.
3. Redline and review SOP's as required.
4. Write clear concise observational memos and assist in investigation of controlled areas.
5. Review environmental data; verify all monitoring data are received from controlled areas prior to incubation of monitoring plates into appropriate incubators.
6. Perform training for Aseptic Area Gown Certification and SOPs.
7. Obtain train the trainer certification.

Twelve (12) months to Twenty-four (24) months:

1. Cross train on multiple sterile filling lines, maintain successful gown certification for ISO 7, 6, and 5 classifications, maintain a high level of right first time adherence to GMP procedures and documentation practices.
2. Assist in environmental investigations.
3. Read testing results, review and trend environmental data
4. Perform leadership function for specified area of assignment, to include training program management for assigned technicians.
5. Assist the Specialist/Supervisor in evaluation of resources needed to complete assigned tasks.
6. Review/Change EM SOPS as require using Master Control

Qualifications:

• HS Diploma required; AA degree preferred
• Minimum 1-year pharmaceutical or laboratory experience desired;
• Knowledge of cGMP's, operation of autoclaves, aseptic technique, and basic computer skills desired;
• Must be able to read and understand directions dictated in procedures with little to no assistance;
• Write clear and accurate memos using correct spelling, punctuation and grammar;
• Understand aseptic processing concepts and apply those concepts to job tasks and evaluation of situations.
• Must communicate clearly with other departments on Environmental Monitoring and other quality issues;
• Must be able to work closely with other production, validation and maintenance/engineering personnel as well as members of the EM Lab;
• Must be willing and able to ask appropriate questions in order to investigate situations surrounding environmental issues.
• Must be able to use available information to make simple decisions on environmental issues and who to contact in these cases;
• Will usually be expected to ask the supervisor/specialist to confirm/negate the proposed decision;
• Handle multiple tasks with minimum supervision and set priorities based on department priorities;
• Evaluate situations involving processes and quality and make appropriate decisions under supervisor guidance;
• Handle continual change in schedules, processes and procedures.
• The incumbent must have the ability to learn the involved factors and evaluate situations. In most cases, recommendations made by the incumbent will be reviewed by the supervisor/specialist prior to implementation.
• The incumbent must work independently and follow procedures accurately without close supervision, take responsibility for completing job tasks, following procedures and proper reporting of any deviations to procedure and be accountable for the accuracy of work performed.
• Environmental Monitoring results are a requirement for product release. Therefore, work has to be completed and reported correctly and completely. Any deviation may have dramatic impact on product release. Procedures must be followed and any deviations must be reported and handled appropriately.
• MS Word, Excel
• Software Aptitude
• Ability to work with computer and tablets
• Mechanical Aptitude
• Manual Dexterity

Shift:Weekday Days_ Monday - Wednesday & Every other Thursday 4:00pm - 4:30am

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $22.98/hr. with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.
  • Shift Differential pay is available for this position, and is determined by hours worked on selected shift.

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com