Quality Technician - Environmental Monitoring
Simtra BioPharma Solutions · Bloomington, IN
- Level
- Technician
- Team
- Quality
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Simtra BioPharma Solutions (pharma & life sciences) in Bloomington, IN.
- Day to day
- some off-shift / weekend coverage
- Openings
- 4 with this title at this site
Read from the posting. The full description is below.
How this role compares
Against 23 other live quality postings in Indiana.
- Experience asked
- Not stated
Similar roles usually ask 4+ years.
Skills these teams ask for most
- ✓ Team leadership 42%
- Root cause 33%
- FDA / GMP 29%
- Validation (IQ/OQ/PQ) 25%
- ISO 9001 21%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Simtra BioPharma Solutions
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How does off-shift and weekend coverage work?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Simtra BioPharma Solutions in Bloomington
15 other open roles at this site.
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- Director, Operational Excellence · Lean / CI · Director+
- Manufacturing Supervisor, Weekend AM · Manufacturing · Supervisor
- OPEX Process Specialist · Lean / CI · Specialist
- Manufacturing Supervisor, 1st Shift · Manufacturing · Supervisor
Full description from Simtra BioPharma SolutionsAs posted on their careers site.ShowHide
responsibilities
- ◆Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
- ◆Documents and processes samples in a Laboratory Information Management System (LIMS).
- ◆Performs real time risk assessments of the manufacturing areas and process.
- ◆Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements.
- ◆Will be required to recognize and escalate non-conformances.
qualifications
- ✓High school diploma or GED.
- ✓Prior experience preferred.
- ✓Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, LabWare, etc.)
- ✓Must be able to communicate well.
Physical / Safety
Requirements
- ✓Must be able to gown qualify for Grade C/D area.
- ✓The position sometimes requires extended periods of standing.
- ✓Must be able to wear applicable Personal Protective Equipment.
- ✓Duties may require overtime work, including nights, holidays, and weekends
- ✓Use of hands and fingers to manipulate office and laboratory equipment is required
- ✓Must be able to lift 20 lbs.
- ✓Must be able to qualify for 20/25 corrected vision and pass color blindness test.
responsibilities
of the job. Simtra reserves the right to make modifications based on business requirements.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
Show full description ↓Show less ↑
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
This role
The Quality Technician - Environmental Monitoring is an entry-level position in the Quality Assurance Line Operations group. This position works independently to perform routine sampling and process samples in support of the Quality department. This position reports to a Quality Line Operations (QALO) Supervisor.
The working hours for 1st shift are Monday-Thursday 6a-4:30p
The
In return, you’ll be eligible for [1]
- •Day One Benefits
- •Medical & Dental Coverage
- •Flexible Spending Accounts
- •Life and AD&D Insurance
- •Supplemental Life Insurance
- •Spouse Life Insurance
- •Child Life Insurance
- •401(k) Retirement Savings Plan with Company Match
- •Time Off Program
- •Paid Holidays
- •Paid Time Off
- •Paid Parental Leave and more
- •Adoption Reimbursement Program
- •Education Assistance Program
- •Employee Assistance Program
- •Community and Volunteer Service Program
- •Employee Ownership Plan
- •Additional Benefits
- •Short and Long-Term Disability Insurance
- •Voluntary Insurance Benefits
- •Vision Coverage
- •Accident
- •Critical Illness
- •Hospital Indemnity Insurance
- •Identity Theft Protection
- •Legal and more
- •Onsite Campus Amenities
- •Workout Facility
- •Cafeteria
- •Credit Union
[1] Current benefit offerings are in effect through 12/31/26
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and