We are seeking qualified individuals to join us as Quality Assurance Specialist. Core duties and responsibilities include the following: Job Duties: • Support Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints. • Provide direction, assess and remediate, as appropriate, current and previous validation documentation, including conducting gap assessments, risk assessments, and development of standards. • Review/approve OOS, deviations, CAPAs, SOPs, and operation documents. • Create and provide guidance on phase-appropriate processes and systems. • Review Risk Assessments, Process Development Reports, and Protocols. • Quality support of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner. • Quality support and approval of validation related documentation (e.g., IQ, OQ, PQ, etc.); this includes process, facilities, utilities, equipment, test methods, cleaning and software validations. • Work with Operations, Manufacturing, Quality Control, and Validation to maintain a validation assessment plan for all GXP assets, buildings, systems, including laboratory instrumentation and systems. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Support the recall process including initiation, customer and regulatory notification, and product withdrawal. • Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes. Competencies: • To perform the job successfully, an individual should demonstrate the following competencies: • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations. • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed. • Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values. • Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence. • Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Requirements • Bachelor's Degree in Engineering, Life Sciences, Chemistry, or related field • 3+ years in Manufacturing or Quality Control in a pharmaceutical, medical device or drug manufacturing company • 2+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company • Strong GMP knowledge and in depth understanding of ICH and FDA regulations • Thorough understanding of problem-solving and quality improvement tools and techniques • Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment Benefits • Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) • Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). • Disability insurance 50% standard employer paid. • 401k 10% 1:1 match • PTO policy. 10 days PTO • Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25 • Carpool, clean air vehicle, and cell phone reimbursement • Employee rewards and recognition program • Company organized social events • Quarterly sponsored team building activities