Associate, Environmental Monitoring - Nights

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 Environment Monitoring Associate (EM) 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. Essential responsibilities include but are not limited to:

Within the first Six (6) Months you will:

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 required using Master Control.

Qualifications:

• HS Diploma required. Associate degree preferred.
• Previous experience working with Microsoft office (word, excel) required.
• Must be able to read and understand directions dictated in procedures with little to no assistance;
• Must communicate clearly with other departments on Environmental Monitoring and other quality issues;
• 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;
• 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
• Must have dexterity, and physical balance to perform aseptic gowning requirements. Ability to lift 25 lbs unassisted, pushing, pulling, prolonged standing and sitting, twisting.

Shift: Nights

Compensation:

• This position starts at $22.25 per hour, with opportunity for growth, promotion and annual raises.
• This position is eligible for a shift premium of $2.00 per hour worked between 3pm and 11pm, and $2.50 per hour worked between 11pm and 7:30am.
• This position is eligible for an aseptic premium of $2.00 per hour worked in qualifying aseptic areas.

Benefits:

• 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

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*Please click on the Spokane, WA link*

Jubilant HollisterStier is an EEO/AA Employer.

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:

Packaging Technicians will routinely inspect products using manual or semi-automatic inspection processes. Products to be inspected are provided in a variety of vial sizes and fill volumes. Technicians will operate critical processing equipment within the SVP I&P facility according to SVP SOPs and cGMP. Accurately complete documentation for operations performed. Performance of cleaning, operational checks, and minor adjustments to equipment, as well as cross-training, are all also required. Essential responsibilities include but are not limited to:

1. Pass hand inspection qualification program. Must pass all Dabrico inspection quadrants within 90 days as a requirement for continued JHS employment and progression to Process Tech II. Inspection qualification program must be maintained annually.
2. Inspect product at assigned areas to ensure production of quality products.
3. Operation of the following equipment within SVP: Inspection equipment, Taper and Packaging equipment, and any other equipment used by SVP Packaging as required.
4. Read and follow established Standard Operating Procedures covering operation and documentation of production processes.
5. Accurate documentation of production processes on production records using GDP.
6. Perform accountability of product components at appropriate stages of production process.
7. Perform and document operational checks of assigned pieces of equipment. Minor adjustments to equipment as needed to keep production line running.
8. Perform equipment set-up and changeover and clean up appropriate for scheduled production run.
9. Maintain a clean work area.
10. Receive any training or education necessary to the performance of an assigned activity.
11. Other tasks as assigned by Supervisor or Specialist.
12. Must have passed hand inspection qualification program and all Dabrico inspection quadrants.

Qualifications:

• High school diploma or equivalent required.
• Pharmaceutical Packaging or Manufacturing Production/Equipment experience desired.
• Manufacturing production and equipment operation experience is desired.
• Ability to learn, understand, and follow current Good Manufacturing Practices and Standard Operating Procedures required.
• Legible handwriting required. Basic computer skills and mechanical aptitude required.
• Ability to work overtime required, including extended or weekend hours, as necessary.
• Ability to operate semi-automatic inspection equipment, pallet jack, and fork life desired.
• Physical Requirements: Ability to lift 50 lbs unassisted. 14/14 corrected near vision. Must be able to pass vision acuity test and meet color deficiency standards.
• Repetitive activities. Prolonged Sitting and Standing. Frequent work above the shoulders.

Shift: Nights

Compensation:

• This position starts at $17.52 per hour, with opportunity for growth, promotion and annual raises.
• This position is eligible for a shift premium of $2.00 per hour worked between 3pm and 11pm, and $2.50 per hour worked between 11pm and 7:30am.

Benefits:

• 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

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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: