Job Description
Overview
CSBio is a peptide contract manufacturing company founded in 1993. This posting is for the role of Associate Director Quality Assurance. Base pay range is $125,000.00/yr - $175,000.00/yr. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.
Responsibilities
- Host and provide responses to client audits and regulatory inspections
- Oversee Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints
- Provide direction and strategy to assess and remediate 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 and approve Risk Assessments, Process Development Reports, and Protocols
- Quality oversight of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner
- Quality oversight 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 establish, develop, communicate, and 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
- Manage 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
- Manage, develop and mentor staff
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
- 8+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company with at least 4 years of managing Validation and Quality Systems activities
- 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 and Vision details vary by plan
- Basic life ($20,000) and optional supplemental life insurance
- Disability insurance 50% standard employer paid
- 401k 10% 1:1 match
- PTO policy: 10 days PTO
- Companywide paid holidays
- Carpool, clean air vehicle, and cell phone reimbursement
- Employee rewards and recognition program
- Company organized social events and quarterly team-building activities
Location: Santa Clara, CA
Job function: Science
Industry: IT Services and IT Consulting
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Job Tags
Full time, Contract work,