Job Summary 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.Additionally, the position is responsible for promoting and fostering a work environment that is safe and conducive to employee development and where Purdue’s values are demonstrated and practiced. Primary ResponsibilitiesResponsible 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.Communicate and motivate employees by making clear how their work objectives are directly linked to Purdue overall strategy. Also communicate strategic expectations throughout the organization and translate those expectations into specific work objectives. 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 Abilities 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.Detail-oriented.Strong analytical ability.Experience in laboratory information management systems, chromatographic data systems, and Microsoft Office applications.Ability to provide excellent customer service, manage others, and collaborate with lab personnel.Ability to work independently under remote supervision.Ability to adapt to a fast-changing work environment.Ability to be flexible and change as business grows and changes.Ability to work collaboratively as a team.Ability to prioritize and meet deadlines.Problem solving, solution oriented and production driven. Supervisory Responsibilities (if Applicable) Directly responsible for operative personnel in daily activities including all those required to meet production schedules. Reports to and seeks guidance as needed from the Operations management team. Physical and EnvironmentalPerform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting. Ability to work a 12.5 hour per day/3-day work week, Friday - Sunday; 36 hours per week with overtime as required. Manager Responsibilities (if applicable)Chemists (Various levels and experiences) Additional InformationThe job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.Purdue Pharma does not sponsor or facilitate any U.S. work/intern or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.