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Quality Associate, Pharmaceutical Manufacturing - 2nd Shift
Particle DynamicsSeymour, IN, US30+ days ago
Job type
- Full-time
Job descriptionPerform all activities in compliance with Particle Dynamics' SOPs, and applicable regulations (FDA, EU, USP / NF, etc.). Provide oversight to ensure : All GMP activities are performed in compliance with Particle Dynamics' approved procedures. Lab 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 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 Draft revisions to GMP documents and initiate change control as appropriate. 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. 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!
Job Description
Job Description
Pay rate will be based on experience!
Particle Dynamics creates pharmaceutical, nutraceutical, 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 climate controlled!
- We work hard but don't require employees to work 6-7 days a week - we promote a healthy work / life balance!
AND....WE WORK 8 HOUR SHIFTS!!
We are currently seeking a Quality Technician with 2nd shift hours! Base hours of 3PM-11 : 30PM with flexibility.
Primary Responsibilities :
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.
Essential Job Functions (Including, but not limited to) :
Serve as backup to Quality chemist for all analytical testing.
Check and approve manufacturing documentation and / or cleaning in accordance with approved procedure.
Ensure compliance with Good Documentation Practice.
Assist in performing OOS, Event and Deviation investigations.
Knowledge / Skills / Abilities
Education / Experience
Benefits :
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Manufacturing Associate 2Nd Shift • Seymour, IN, US
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