Quality Associate, Pharmaceutical Manufacturing (GMP), 1st Shift Hours, Monday-Friday
Particle Dynamics
- Seymour, IN
- Permanent
- Full-time
- 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!
- 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.