Quality Associate, Pharmaceutical Manufacturing

1 week ago

Seymour, United States Particle Dynamics Full time
Job DescriptionJob Description

THE PAY RATE FOR THIS POSITION WILL BE DETERMINED BY EXPERIENCE

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

We are currently seeking a Quality Associate for our Pharmaceutical Manufacturing facility located in Seymour, IN:

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

Primary Responsibilities:

  • 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.

Essential Job Functions (Including, but not limited to):

  • 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.

Knowledge/Skills/Abilities

  • 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.

Education/Experience

  • 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.

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