Quality Assurance Manager

Stokes Pharmacy•Mount Laurel Township, NJ

1d•$80,000•Onsite

About The Position

The Quality Assurance Manager will oversee operations at STEP Labs Testing Facility. This includes, but is not limited to, managing quality systems, quality procedures relating to raw materials and products, method validations, managing day-to-day Quality Assurance operations, and the release of test reports within an analytical environment. This position leads the ongoing process focused on assessing, evaluating, and improving all aspects of quality management to enhance performance and maintain data reliability. The Quality Assurance Manager reports directly to the Laboratory Director/Managing Director.

Requirements

Minimum of 8 years of experience in analytical testing, microbiology testing, or pharmaceutical manufacturing, or applicable field, without a degree
Minimum of 6 years of experience analytical testing, microbiology testing, or pharmaceutical manufacturing, or applicable field, with degree
3+ years’ experience in a supervisory role, preferred
Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred
Excellent communication and technical writing abilities
Extensive knowledge with GxP, FDA, ICH, ISO, USP, PDA, DEA, and OSHA requirements
Proficient with Microsoft Office applications (Word, Excel, etc.)
Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently and as part of a team
Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
May need to lift up to twenty-five (25) pounds on occasion
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.
Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.
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.

Nice To Haves

3+ years’ experience in a supervisory role
Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field

Responsibilities

Ensure compliance with FDA regulatory guidance, ISO 17025, and company policies
Lead regulatory inspections and audits by FDA, applicable regulatory bodies, and accreditation bodies
Develop Quality Assurance procedures to maintain compliance and enhance reliability of laboratory procedures
Monitoring applicable regulatory requirements for updates
Perform investigations for deviations, discrepancies, and out-of-specifications
Lead investigations for deviations/discrepancies for laboratory departments
Perform root cause analysis using industry standards, such as FMEA, 5Whys and Fishbone diagrams
Perform trend analysis of critical process parameters and evaluate KPIs to determine procedure effectiveness
Assist in the development and execution of relevant corrective and preventative action
Oversee training program to ensure staff is adequately trained and perform competency assessments as needed
Ensure that the company policy for data integrity and ALOCA+ principles are met in the laboratory
Oversee equipment and instrumentation calibration, validation, and maintenance program
Periodic review of data to comply with Laboratory Procedures, Test Method, Protocols, GxP, and work with personnel for any correction and promote a CGMP culture
Lead in the development and implementation of new and existing processes: Quality Management System, Sample Coordination, Laboratory Information Management System, Environmental Monitoring System
Oversee the review and approval of testing documentation to support quality release of test reports in a timely manner
Able to multitask, to work with dynamic changes of plans, to communicate with cross functional teams, complete the work within the timelines
Oversee change control management program and documentation archival
Work closely with Quality Control to evaluate all customer issues, perform root cause analysis and respond appropriately
Lead in development and maintaining of quality inspection process for analytical and microbiology testing
Oversee performance of routine audits of processes and perform gap analysis
Monitor controlled substance chain of custody transfers throughout laboratory operations
Support Environmental, Health & Safety, and Logistic Teams