QC supervisor, Weekend Shift (6:00-6:30pm )

Job Description

The QC Laboratory Supervisor will provide daily oversight of laboratory operations in the Quality Control department; including scheduling activities, overseeing training and providing input regarding team members overall job responsibilities including job proficiency and adherence to standard procedures and policies. The Supervisor will oversee a team performing a variety of analyses, sampling and data review of: raw materials, investigational samples, process validation samples, method transfer samples, finished product release and stability samples, and microbiological samples in accordance with cGMP, GLP, DEA and company policies and procedures.

Primary Responsibilities

• Responsible to ensure all testing of raw material, microbiological, stability and release samples occur in a timely and organized manner and in accordance with cGMP, GLP, DEA and company policies and procedures.
• Write, revise, develop, evaluate, and review Standard Operational Procedures. Focus on continuous improvement ensuring regulatory compliance and lab efficiency. Ensure data integrity and accurate documentation of all necessary and relevant information in a clear and concise manner as per cGMPs.
• Identify areas of improvement and implement efficient solutions that increase compliance, data integrity, efficiency and reduce chance of errors.
• Communicate openly within and between groups to provide and gather information, to optimize the use of resources and to optimize efficiency.
• Provide training and assistance to Quality Control group members. Formulate development plan for group members and develop succession plan.
• Oversee and actively participate in investigations, problem solving and troubleshooting for areas of responsibility.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices. Assess equipment needs with regards to new technologies and capacity needs. Identify opportunities for out-sourcing of testing to optimize cost and efficiency.
• Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
• Manage and maintain project timelines and provide leadership supporting method improvements and development/ validation activities. Perform data analyses and present findings and recommendations both verbally and in writing.
• Work collaboratively in cross-functional teams to achieve goals and objectives relative to development programs and overall site compliance.
• Review and author method validation /qualification/transfer documents in compliance with cGMP, ICH, USP, industry regulations, and company procedures. Author, review and approve operational and maintenance procedures relative to laboratory operations.
• Improve and develop analytical methods primarily utilizing HPLC, GC, and Wet Chemical methods of analysis.
• Interface and provide analytical support to manufacturing and development operations.
• Provide technical support in testing and instrument setup, in troubleshooting methods, method improvement, method development and validation.
• Reinforce proper compliance with cGMP, SOPs and FDA guidelines to maintain control requirements. Trouble shoot, identify problems, and make well informed decisions.
• Perform other related assignments and duties as required and assigned.

Education and Experience

• A Bachelor’s degree in biological, chemical, environmental, or related sciences from an accredited college or university.
• A minimum of 5 years of pharmaceutical experience in a laboratory environment required (preferably in the area of solid oral dosage) and minimum 3 years of experience in a supervisory role.
• Necessary Knowledge, Skills, and Abilitie
• Direct experience in a laboratory environment in solid oral dose (highly preferred).
• Technical competence in analytical chemistry and/or microbiology.
• HPLC, GC, Dissolution, Automation, Spectroscopy, UV/VIS, , and IR experience preferred.
• Must have a comprehensive knowledge of cGMPs, DEA and FDA requirements.
• Excellent verbal and written communication skills including technical writing.
• Ability to work collaboratively as a team.
• Ability to prioritize and meet deadlines.
• Problem solving, solution oriented and production driven.