QA Team Lead, Technician, and InspectorPL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. Serve as QA Team Lead, technician, and inspector, and prepare statistical process control data. Ensure all products and materials shipped or transferred are accurately identified and accounted for.
Work schedule: Monday - Friday 5:00 am - 1:30 pm Pay Range: $19 - $21 (DOE)
JOB QUALIFICATIONS:
High School graduate or GED required. Good Math skills. Detail oriented. Knowledge of GMP is preferred. Experience in working with SOP's is preferred. Knowledge of MS Word and database software preferred. Some experience in manufacturing environment. Able to speak, read and write English. Training available for those who meet the minimum requirements. Basic statistical skills (mean, mode, medium, standard deviations calculation)
POSITION RESPONSIBILITIES:
Oversee and perform Inspections, sampling and checking of manufacturing processes. Key member to work with operations for continuous improvement in the manufacturing process. Able to be a back-up position as a document control specialist. Good documentation practices. Review and verify accuracy and completeness of batch record or related to in-process and finished products. Inspect, and release production line. Inspect components and finished good products. Identify quality issues and assist with resolutions. Organize team to be cross trained to perform QA inspections in packaging lines Oversee and Control and upkeep of company's retain samples program Oversee and perform In-process testing on bulk products that include lab equipment such pH, viscometer, and balances Oversee and perform testing of rinse water samples from equipment, such as mixing tanks, holding tanks, and filling lines using lab equipment Verify cleanliness and equipment for assembly of compounding and filling process Oversee and schedule with Quality Control in the samples obtained for stability program Preparation and assisting in all validation processes associated with compounding and filling such as swabbing, collection of samples, and in-process testing. Oversee, perform and schedule customer complaint review associated with batch records and complete reports to Manager. Issuance of documents through Agile systems to all departments Support other QA functions as needed. Perform all functions of QA Technician Perform documentation control process; Perform any other functions requested by supervisor. Must be able to make sound judgments regarding production line inspection requirements. Must be able to make reasonable decisions on the acceptance of the finished products and component quality inspection independently. Must be able to understand calibration requirements with minimum supervision. Must be able to verify the accuracy of batch record calculation and information on validation reports, etc. Perform components and raw materials transactions in Oracle inventory system and batch record Record and input Resource hours in documents and Oracle inventory system Assign LPN's to finished goods and returns Perform Discards reporting in Oracle inventory system Cleaning agent issuance documents to compounding and filling departments Good documentation practices. Review and verify accuracy and completeness of batch record or related to filled units and finished labeled products. Inspect, and report production line. Verify and Report components and finished good products in batch record and Oracle inventory system. Identify quality issues and assist with resolutions. Perform reconciliation of raw materials, components and finished goods products in Oracle inventory system. Support other QA functions as needed. Support all general safety, food safety and all pharmaceutical compliance requirementsPHYSICAL REQUIREMENTS: Walking up to 6 hours per day Sitting up to 2 hours per day Occasionally lift up to 30 lbs.
BENEFITS:
PLD is a proud employer offering many corporate benefits, including: Medical and Dental Benefits Vision 401K with employer match Group Life Insurance Flex Spending Accounts Paid Time Off and Paid Holidays Tuition Assistance Corporate Discount Program Opportunities to Flourish Within the Company PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
