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The QC department is responsible for microbiological and analytical cGMP testing of sterile and non-sterile products, raw materials, components and utilities. This includes routine microbiological and analytical testing of products for release and stability, development and validation of microbiological and analytical methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility/utilities/equipment, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.
The QC Manager coordinates and oversees all activities in the QC Microbiology and QC Chemistry departments and works closely with manufacturing and Quality Assurance for harmonization between departments.
Responsibilities:
The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies.
Specifically, while working independently, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs), USP/NF, or written work instructions:
Manage direct reports for administrative/HR purposes such as time off and sick days.
Responsible for interviewing, hiring, coordinating training, and terminating direct reports. Perform annual reviews for all direct reports. In addition, execute disciplinary actions, as needed.
Perform review of laboratory notebooks for accuracy and compliance to the analytical method.
Write and perform review of QC reports.
Review investigations, deviations, and CAPAs; coordinate with impacted departments (client) and QA; create and implement appropriate corrective and preventative actions.
Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards
All other duties as assigned by management
Qualifications:
Required:
Education and Experience:
Bachelor s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or equivalent with 5 years of experience in sterile pharmaceutical and/or biotechnology manufacturing.
Or
Equivalent combination of relevant education, experience and training
Supervisory experience in the pharmaceutical/biotechnology/medical device field.
Physical:
Lift up to 35 lbs
Ability to work standing in laboratory for an 8 hour shift
Training:
Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
Knowledge, Skills and Abilities:
Knowledge of microbiological and analytical laboratory techniques
Knowledge of sterile techniques used in the laboratory
Experience working in QC laboratory
Ability to learn new laboratory equipment and techniques
Excellent verbal and written communication skills
Knowledge of cGMPs, USP/EU regulations, and ICH guidelines
Analytical reasoning, root cause analysis and problem solving
Ability to manage direct reports
Technical writing: write, read, understand, and interpret technical writing and instructions
MS Office skills; particularly Word and Excel
Math and calculation skills
Multitask and coordinate with operations and quality assurance simultaneously
Work with a wide range of people to solve problems and resolve issues
Work in a fast-paced environment
Ability to maintain flexible task schedule and workflow
Highly detail oriented with good record keeping skills
Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team
Preferred:
Education and Experience:
Master s Degree in Microbiology, Biology, Engineering, Chemistry, Biochemistry or equivalent with 5 years of experience in sterile pharmaceutical and/or biotechnology manufacturing.
Knowledge, Skills and Abilities:
Knowledge of sterile manufacturing process and procedures
Full Time