Implementation Consultant

Overview:

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.

Requirements

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 all internal and outsourced QC laboratory operations. Provide the primary technical support for the QC laboratory and ensure that all testing and investigation, deviations are performed in a high quality and timely manner.
  
• Responsible for managing stability programs, and the release of drug substance, and finished drug products.
  
• Responsible for managing QC department validation and calibration activities.
  
• Coordinate QC support activities of the sterile manufacturing areas, such as environmental monitoring, in-process sampling, utility sampling and formulation.
  
• Coordinate QC personnel activities to ensure that all testing and calibrations are completed according to schedule and meet all CGMP requirements.
  
• Responsible for monitoring instrument qualifications and ensuring that qualifications of analytical instruments are up to date and meet regulatory requirements.
  
• Develop test protocols, review and write technical reports, write SOP s, and review stability data.
  
• Work closely with QA to implement procedures in compliance with regulatory requirements.
  

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