Bachelor's Degree in Engineering, Life Sciences, Chemistry, or related field
5+ years in Quality Assurance within pharmaceutical, medical device or drug manufacturing
Strong knowledge of GMP and deep understanding of ICH and FDA regulations
Familiarity with problem-solving and quality improvement tools and techniques
Ability to collaborate effectively in a cross-functional, fast-paced environment
Responsibilities
Support the Quality Management System, including quality investigations and document control
Direct and remediate validation documentation through gap and risk assessments
Review and approve OOS, deviations, CAPAs, SOPs and operational documents
Create guidance on phase-appropriate processes
Review Risk Assessments and Process Development Reports
Provide quality support to ensure compliance in validation processes
Manage and mentor QA staff
Benefits
Medical, dental, and vision insurance with substantial employer contribution
Basic and optional supplemental life insurance
Employer-paid disability insurance
401k plan with 10% 1:1 match
10 days of PTO and paid holidays
Reimbursements for carpooling and clean air vehicle expenses
Employee rewards program and social events
Quarterly team building activities
Full Job Description
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.
Manage, develop and mentor staff.
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
5+ 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 90% for Employee and 75% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
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
Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
Disability insurance 50% standard employer paid.
Carpool, clean air vehicle, and cell phone reimbursement
