TOLMAR Inc. QA Annual Product Review Supervisor in Fort Collins, Colorado
Purpose and ScopeThe QA Annual Product Review Supervisor is primarily responsible for themanagement and completion of the Annual Product Reviews (APRs) for Tolmar. The key deliverables of this role are to ensure APRs are completed timely andin compliance with procedures. The APRs are utilized as a communication toolfor Site Senior Management to evaluate manufacturing processes,specifications, process controls, trends, etc. for continuousimprovement and preventive action in order to ensure we maintain thereliability of our product supply.Essential Duties and Responsibilities Responsible for the management of each assigned US and Non-US AnnualProduct Review (APR). Collaborate with various departments that have responsibilities to theAPR process and ensure that data is supplied on time and is sufficient andcompliant with appropriate procedures. Support statistical analysis of data, identify trends in theproduct/process data that can affect product quality, and summarize theresults, data analysis, and conclusions in technical reports. Author APRs, SOPs, change controls, statistical and riskassessments for site APRs for commercial projects relating to Quality. Assist departments in preparing and analyzing their data (e.g.,manufacturing and laboratory analytical historical data). Assure that Tolmar employees understand regulations and current industrypractices related to APRs through training and education. Assure compliance with all applicable regulations by proactivelyinterpreting regulatory and compliance requirements, establishing andmaintaining systems related to the APR process. Complete document updates and process improvements. Perform other related duties as assigned.Knowledge, Skills and Abilities Advanced technical writing skills. Familiarity with 21CFR and CpK process control measurements. Strong critical thinking and deductive reasoning skills. Experience with statistical software packages (e.g. mini Tab) and MS Office. Excellent interpersonal and communication (written and verbal) skills Strong training, coaching and mentoring skills. Ability to influence and train others. This position needs to be able tochange the behaviors of others through coaching and mentoring. Ability to interface positively with Regulatory Agencies, vendors andcompany departments. Strong aptitude in Microsoft Word, Access and Excel. Working knowledge in drug or device cGMP. Advanced knowledge of QA principles, concepts, systems, industrypractices and standards. Skill in organization and attention to detail. Ability to work independently. Advanced procedure and report writing capability.Core Values The QA Annual Product Review Supervisor is expected to operate withinthe framework of Tolmar s Core Values:o Consistently operate with the highest standards of ethics and compliance.o Take ownership of your actions, success and setbacks.o Respect each other and understand that honest collaboration is at theheart of our company success.o Go the extra mile to make things happen.o Be committed to all we do and the patients we serve.o Embrace change with enthusiasm.o Strive to learn about and understand the needs of customers andpatients, and take action with great speed and efficiency no matter the task.Education and Experience Bachelor s Degree in science, engineering or related field required. At least 8 years of related experience in CGMP regulated environmentrequired. At least 5 years of experience as a Quality Engineer or equivalent rolewith demonstrated success leading, driving, and/or implementing the APRprocess in the Medical Device, Pharmaceutical, or Life Science industries requi Previous supervisory experience preferred.Working Conditions Working conditions are normal for an office environment. May requireoccasional weekends and/or evening work.