San Antonio, TX | Temp/Contract to Direct
Summary: Maintains quality compliance by evaluating quality environment; developing quality and compliance strategies, goals, and standards; conducting audits; developing improvement plans; managing staff.
Responsibilities include but are not limited to:
· Accomplishes quality assurance compliance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
· Achieves quality assurance compliance operational objectives by implementing production, productivity, quality, and customer-service standards; determining system improvements; implementing change.
· Meeting quality assurance compliance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating remedial corrective action.
· Evaluates regulatory climate by monitoring and analyzing regulations, guidelines, and standards, including International Committee on Harmonisation (ICH), International Organization on Standardization (ISO), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA); leading cross-functional teams; identifying potential vulnerabilities.
· Establishes quality goals and requirements by designing, organizing, and promoting a quality culture; developing and disseminating standards, metrics, standard operating procedure (SOP) management, and contractor document and production records guidelines.
· Maintains quality compliance by developing and enforcing plans, programs, policies, procedures, and SOPs; conducting audits; evaluating documentation; developing improvement plans; preparing and delivering training courses.
· Prepares compliance reports by collecting, analyzing, and summarizing data and trends.
· Protects organization’ s competitiveness by keeping information confidential.
· Updates job knowledge by tracking emerging trends in good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory requirements; completing benchmarking studies; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
· Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments;
SKILLS/QUALIFICATIONS AND KNOWLEDGE:
· GCP, Analyzing Information, Decision Making, Strategic Planning, Quality Management, Supervision, People Management, Audit, Verbal Communication, Informing Others, Biohazard Safety
Verisurf Software Experience is a PLUS.