Job Description

Job Description

Job Description

COMPENSATION BASED UPON EXPERIENCE!

Particle Dynamics creates pharmaceutical, nutraceutical, food and over the counter products that will improve the health of consumers around the world! We are a 3-shift 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 clean & climate controlled!
• We work hard but don't require employees to work 6-7 days a week - we promote a healthy work/life balance!

Primary Responsibilities:

The Quality Associate performs all activities in compliance with Particle Dynamics' SOPs, and applicable regulations (FDA, EU, USP/NF, etc.). The Quality Associate also provides oversight to ensure:

• Incoming, in process (if applicable), and finished product testing is completed accurately and expediently, and all associated documentation is completed according to procedure to assure the 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:

• Perform line checks/start-up checks/cleaning verification as needed to support Operations.
• Review batch records and manufacturing documentation to confirm completion and compliance with associated procedures.
  • Notify Management immediately when discrepancies are identified.
  • Disposition finished products as necessary.
• Perform USP Water sampling and testing and Environmental Monitoring in accordance with Particle Dynamics' procedures.
• Monitor product quality to ensure compliance with standards and specifications by conducting chemical or physical laboratory testing.
• Prepare C of A, C of C, or C of T, as appropriate.
• Order and inventory reagents to maintain adequate supply for the established schedule or when notification of increased production is provided.
• Maintain retention samples of Raw Materials and Finished Products and the associated documentation.
• Maintain the stability program.
• Provide guidance to Document Control to ensure necessary stability samples are collected.
• Ensure stability testing is conducted in accordance with the established schedule.
• Ensure stability samples are sent to third-party laboratories in a timely manner.
• Maintain the stability log.
• Report results on time.
• Notify Management/Leadership of any Stability or Finished Product OOS results.
• Initiate an NOE for OOS results.
• Coordinate with Maintenance to ensure Laboratory instrumentation and data loggers are calibrated on the required schedule.

• Ensure temperature monitoring of warehouse and storage refrigerators is documented per procedure.
• Incoming Materials
• Prepare required Quality documentation.
• Perform sampling per procedure.
• Notify Management/Leadership of any OOS conditions.
• Disposition incoming materials as necessary.
• Maintain laboratory notebooks in accordance with procedure.
• Maintain laboratory cleanliness and order.
• Remain vigilant in regard to continuous improvement.
• Evaluate existing systems for inefficiencies and propose improvements to management.
  • Actively work to improve these systems with management approval.
  • Initiate any necessary documentation for changes.
• Annually review compendial methods used for testing products or raw materials.
• Notify Management/Leadership of pending changes.
• Initiate Change Control for these.
• Triage and investigate NOEs and write summary reports as necessary and recommend CAPAs if applicable.
• Participate in daily and weekly audits of the facility.
• Other duties as assigned.

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 - 9 ANNUALLY!

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 - 9 ANNUALLY!

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