THE PAY RATE FOR THIS POSITION WILL BE DETERMINED BY EXPERIENCE!!

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 St. Louis/Brentwood:

• Sample and perform testing of raw materials, finished product, stability, in-process, rinse water and purified water as required.
• Inspect manufacturing areas to ensure compliance
• Assures that the products are processed in accordance with the master batch record and have the safety, identity, quality, and purity they purport to possess prior to release.
• Also assures that manufacturing, handling, testing and distribution of products are done according to all governmental, customer and company requirements.

Essential Job Functions:

• Perform all responsibilities in compliance with Particle Dynamics SOPs and FDA regulations.
• Work with Quality department personnel.
• Perform functions as directed.
• These functions may include, but are not limited to:

• Sample incoming components for conformance to specifications.
• Serve as backup to Quality chemist for all analytical testing.
• Assist in maintaining lab and equipment cleanliness.
• Assist in review/approval/filing of internal and external test results.
• Download, print, and file environmental data.
• Work in a safe, effective, and efficient manner.
• Always demonstrate a professional attitude.
• Willingness to work overtime to meet testing demands.
• Other duties as assigned by Site Leadership Team.
• Assist in the performance of out-of-specification investigations
• Monitor and archive temperature humidity data
• Conducts routine and scheduled inspections of plant areas, equipment and personnel to ensure cGMP compliance. If discrepancies in cGMP, procedures, systems and techniques are observed an Auditor initiates documents on the area inspection report, documents the incident and forwards to the department manager and the facility, Supervisor.
• Monitors work in process for proper use of materials, correct recordings and possible sources of cross-contamination and report all deviations to the facility, Supervisor.
• Collects samples as called for by protocol requirements to assist with validation sampling as appropriate.
• Reviews product manufacturing records and analytical physical results to assure that all product requirements have been met prior to shipment from the appropriate processing facility.
• Assists in investigations, Deviations, and corrective actions.
• Routinely checks calibration dates on production instruments for current date and informs, Supervisor and Manufacturing Plant Manager of instruments exceeding due dates. Also reports missing calibration stickers when needed.
• Initiates rejection form in cases where the raw material and finished product does not meet specification.
• Inspects and approves use of designated equipment after product change over in the assigned facilities.
• Destroys finished product reserve samples as required per QA authorization.
• Handles special responsibilities such as process/cleaning validation sampling.
• Responsible for notifying management when quality discrepancies are discovered. Assists production to access and resolve processing problems.
• Other related duties as assigned to meet departmental and Company objectives.

Job Specifications:

Knowledge/Skills/Abilities

• Ability to use: Scale Balance, Micrometer, Calculator and Computer.
• Understand the importance of clean processing/equipment work areas.
• Demonstrated ability to read and comprehend written technical procedures as well as revise SOPs as needed.
• Demonstrated ability to comprehend, interpret, enforce and apply written Good Manufacturing Practices and Standard Operating Procedures.
• Demonstrated ability to accurately perform and document math calculations required by work assignments.
• Demonstrated skill in written communication including record keeping.
• Ability to operate equipment utilized in manufacturing function desired.
• Outstanding oral communication and conflict resolution skills.

Education/Experience

• At least some years of college level training in Biology, Chemistry, and Mathematics required. Or at least several years directly related to quality assurance & quality control; similar work experience may be substituted. Priority will be given to candidates with a degree in a scientific area of study or candidates with GMP experience.
• QA Physical testing experience including familiarity with sampling procedures and testing equipment required.
• Experience in inspection of raw materials, in-process and finished pharmaceutical product sampling.
• Minimum of two (2) years' experience or equivalent as Quality Inspector/Auditor in Pharmaceuticals.

Salary : $20 - $100