Quality Control Analyst - Environmental Monitoring - mid shift

Benefits Competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. Conveniently located in Mount Laurel, New Jersey, minutes from Philadelphia and the NJ shore. Summary/Objective This position requires an individual who can work collaboratively with production personnel to optimize quality aspects of operations. Schedule Monday - Thursday 10AM - 8PM Full time Salary Starting at $20.00 hourly depending on experience plus twice yearly bonuses. Essential Duties and Responsibilities Learn aseptic gowning and technique within a cleanroom environment Learn and apply GxP (GMP, GDP, GLP) to operations Perform viable/non-viable environmental monitoring and read/review microbial samples Assist in the media-fill process validations and inspection of filled units Perform document review of operation activities such as cleaning record, line clearance forms, and inventory/equipment checklist Document non-compliance and work with supervisor/lead if further investigation is needed Review production batch records and associated data for product release; determine if records are within cGMP regulations; review data obtained for compliance specifications and report abnormalities Perform audits on aseptic technique and operation documentation Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems Ensure timely assessment and closure of Change Controls Assist with equipment calibration program and maintenance record files Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures Assist in the training of new employees and other technical personnel Required Education and Experience Bachelor’s degree in biology, microbiology, or other related field, or 1 year relevant experience in cGMP environment Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) Must be able to follow gowning/garbing procedures (cannot wear makeup, must remove jewelry before sterile compounding) Must learn and understand 21 CFR Part 210 and Part 211, along with other relevant cGMP regulations Must be capable of working with small, delicate pieces of machinery to complete appropriate dosage forms in a timely manner Must possess strong verbal, written, and oral communication skills Must be able to work independently and with a team Must possess problem-solving skills Ability to recognize priorities and take action; make productive use of time Must exhibit punctuality and low absenteeism Able to sit and/or stand 8-10 hours or more per day as needed Competencies Communication Organizational Skills Problem Solving/Analysis Results Driven Technical Capacity Thoroughness Supervisory Responsibility This position has no supervisory responsibilities. Work Environment This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking. Language Skills Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals. Mathematical Skills Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge. Reasoning Ability Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form. Physical Demands May need to lift up to twenty-five (25) pounds on occasion This position is moderately active and requires standing and walking for a majority of the shift. (8-10 hours) Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affiant Action Employer. #J-18808-Ljbffr