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Particle Dynamics is Hiring a Quality Associate, Pharmaceutical Manufacturing (GMP), 1st Shift Hours, Monday-Friday Near Seymour, IN
Have you ever thought "It would be cool to know the work I do on a daily basis directly impacts the lives of people all around the world"? If so, we could have the perfect opportunity for you!
Simply put, Particle Dynamics creates pharmaceutical, nutraceutical, and over the counter products that will improve the health of consumers around the world! We are an operation offering growth and training opportunities to individuals looking for a change of pace from the big manufacturing facilities. So, what makes us stand out from others?
- We are smaller in size, so we have a tight knit group of employees - it's like family!
- Employees start out with paid time off - no waiting period to take time off!
- We offer a highly competitive benefits package with coverage starting the first of the month following your hire date - benefit coverage starts almost immediately!
- Our pay rates are highly competitive - we pay more for experience and high performers!
- We are a pharmaceutical manufacturer - all our production and packaging lines are climate controlled!
- We work hard but don't require employees to work 6-7 days a week - we promote a healthy work/life balance!
Benefits:
- Health, dental, vision, and life insurance effective the 1st day of the month following a new employees hire date.
- 401k match - 4% of 5% the employee contributes (100% on first 3%, 50% on next 2%) - immediate vesting!
- This position is eligible for the following time off yearly - 80 hours of vacation, 40 hours of sick, 16 hours of personal time - vacation and personal time are available upon hire!
- Uniforms, safety shoes and safety glasses are provided to employees by the company.
- Employees are eligible for paid holidays upon hire - 10 ANNUALLY!
- Perform all activities in compliance with Particle Dynamics' SOPs, and applicable regulations (FDA, EU, USP/NF, etc.).
- Provide oversight to ensure:
- Products are processed in accordance with Particle Dynamics' procedures and the approved batch record to assure safety, identity, strength, quality, and purity they purport to possess.
- All GMP activities are performed in compliance with Particle Dynamics' approved procedures.
- Lab
- Serve as backup to Quality chemist for all analytical testing.
- Perform USP Water sampling and testing.
- Sample and/or test incoming components for conformance to established specifications.
- Assist in maintaining lab and equipment cleanliness and compliance.
- Manufacturing
- Check and approve manufacturing documentation and/or cleaning in accordance with approved procedure.
- Review batch records and manufacturing documentation to confirm completion and compliance with associated procedures.
- Notify management immediately when quality discrepancies are identified.
- Complete Environmental Monitoring in accordance with Particle Dynamics' procedures.
- Documentation
- Ensure compliance with Good Documentation Practice.
- Draft revisions to GMP documents and initiate change control as appropriate.
- Investigations
- Assist in performing OOS, Event and Deviation investigations.
- Recommend CAPA if applicable.
- Quality Technician / Auditor job description is the same. At the Auditor level there are additional expectations, including a greater understanding of the applicable regulations. The Auditor will be responsible for all activities performed as a technician and also participate in evaluation of existing systems, SOPs, etc., for compliance to applicable regulations.
- Willingness and ability to learn.
- Proficient in Microsoft Office products.
- Outstanding oral and written communication skills.
- Ability to accurately perform and document math calculations required by work assignment.
- Detail oriented, meticulous in nature, excellent proofreading skills.
- Excellent organizational/time management skills. Able to multi-task efficiently to meet job demands
- Lab skills preferred.
- Familiarity with Pharmaceutical Manufacturing Operations and GMPs a plus.
- High school diploma or equivalent required, college degree preferred. Priority will be given to candidates with a degree in a scientific area of study or candidates with GMP experience.
Job Summary
Full Time
$45k-56k (estimate)
04/23/2024
05/12/2024
particledynamics.com
SAINT LOUIS, MO
50 - 100
1990
JEFF DORRIES
$10M - $50M
Pharmaceutical
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About Particle Dynamics
For over 30 years, Particle Dynamics has supplied innovative technologies, quality ingredients and custom processing capabilities that deliver solutions for our customers. Simply said, our technologies make our customers products to perform better. We provide particle processing, delivery technologies, and dose manufacturing to the pharmaceutical, consumer health, OTC, and nutraceutical markets. Particle Dynamics is organized around six key Technology and Service lines, including Spray Drying, Continuous Granulation, Microencapsulation, Iron Deficiency Technologies, Dose Manufacturing and Prod ...
uct/Process Innovation Services. In addition, the company holds leading global positions in Direct Compression products such as Direct Compression Calcium Carbonate and Magnesium Carbonate. However ahead of all of the great technologies and products comes our people. Our dedicated employees are the fuel that drives our success, and the Particle Dynamics team is passionate, dedicated, and driven bringing real value to our customers by providing solutions. Our team takes pride in knowing that the products we deliver are positively impacting the human condition; touching millions of people around the globe by addressing major global health challenges such as iron deficiency, anemia, and prenatal nutrition. For those who would like to join our growing team, Particle Dynamics offers a strong benefits package including generous paid time off, company paid disability, matching 401K plan, medical, dental, and vision coverage, and much more! At Particle Dynamics we work closely to ensure our employees and our customers work in partnership, motivated to achieve great things together, and celebrate our common successes!
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