Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
Global Pharma Analytics, Inc. (GPA) is a cGMP contract analytical chemistry laboratory. GPA’s focus is to develop precise analysis to support pharmaceutical, nutritional and specialty chemical companies, from analytical testing and stability programs to consulting services. We are dedicated to helping our customers achieve the highest standard of quality with all their consumer products by supporting each customer’s unique analytical needs with our vast technical experience and integrity.
The Manager, Quality Assurance is responsible for planning and directing quality assurance policies, programs and initiatives. This person will be responsible for being the Quality Management Representative and driving the QA strategy, ensuring that quality is achieved across all areas of the organization. They will be responsible for the management of services and processes that support the core business. They will focus on utilizing best business practice to improve effectiveness and efficiency, by reducing operating costs while increasing productivity.
• Support and maintains an “organizational culture” of quality within the organization.
• Overall responsibility for the management of the Quality Assurance department which includes managing the staff by providing guidance, training, and coaching.
• Functions independent from laboratory operations where QA oversight is provided.
• Functions impartially and is free from any commercial, financial, and other pressure which might influence his/her independent judgment. Maintains knowledge of CGMP, ISO, GLP, and other Quality Systems as required by clients and regulatory authorities.
• Ensures that the management system related to Quality is implemented.
• Maintains the Quality Manual.
• Directs the training program to support CGMP/ISO activities in laboratory operations.
• Responsible for all audit functions within GPA. Acts as host to auditing personnel as required to ensure staff response to internal and external audit plans are maintained, conducted, reported, and responded to in a timely manner.
• Oversees the review process of documents and ensures that proper technical evaluation is completed and documented confirming compliance with approved practices and procedures.
• Ensures documentation suitability against regulatory standards, and provides input on opinions and interpretations related to technical discussions as requested by technical management.
• Determines that no deviation of SOP is made without proper documentation and authorization.
• Reviews final reports to assure the reported test results were verified and approved by technical personnel and that results are reported accurately to reflect the raw data. Oversees tracking and trending of quality systems and presents information/reports to senior level management regarding the status.
• Ensures all controlled documents and records meet CGMP requirements.
• Develops processes and guidelines for quality system management and oversees continuous improvements to ensure enhanced compliance to CGMPs and evolving FDA expectations.
• Identifies staffing requirements, as necessary.
• Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with scientists, process operators, technicians, and engineers.
• Completes quality assurance operational requirements by scheduling and assigning employees; following up on work results.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Lift up to 25 lbs
• Must have demonstrated experience in managing a total quality program in a Pharma/Biopharmaceutical, biotechnology, or Medical Device environment.
• Must have hands-on experience in a pharma/biopharmaceutical CGMP analytical and/or microbiological laboratory.
• High degree of computer, CGMP, and FDA regulation experience. Strong office applications, database and computer hardware; written and oral communication skills. Requires excellent interpersonal skills and ability to supervise, guide, train, and coach others.
• Ability to assess and discuss constructively, with multi-disciplinary departments and/or regulatory personnel, compliance oversight priorities and the interpretation of areas not specifically addressed in the applicable statues, without creation of excessive risk for the corporation.
• Knowledge and experience in organizational effectiveness and operations management.
• Knowledge of business and financial practices Knowledge of human resource principles and practices.Knowledge of management principles and practices.
• Knowledge of project management principles and practices.
• Information technology skills.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
Additional Salary Information: The successful candidate will enjoy a competitive and benefits package commensurate with work experience. We offer Medical, Dental insurance, Vision and life insurance, short and long term disability, as well as flexible spending account and a 401(K). Somahlution, Inc. is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, sexual orientation, national origin, age, physical or mental disability, citizenship status, veteran status, or any other characteristic prohibited by state or local law. We are dedicated to providing a work environment free from discrimination and harassment, and where employees are treated with respect and dignity. This policy reflects the organization’s belief that providing equal opportunities for all employees is both a moral responsibility and good management practice.