Quality Assurance Project Manager
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Quality Assurance Project Manager is an individual contributor who solves a variety of issues following cGMP regulations and company standards.
Key Responsibilities:
- Maintain a state of inspection readiness.
- Provide input to the development of personal performance goals and departmental objectives.
- Generate QA trends for client Business Review Meetings
- Collaborate with Management to establish and meet targets and timelines.
- Serve as a Quality representative on cross-functional and multi-site teams as well as routine client meetings
- Identify and recommend solutions to potential procedure, process and system gaps.
- Point of contact to customers in support of departmental functions.
- Participate in the design and implementation of department and cross-functional initiatives.
- Apply basic theory and technical principles to address moderately complex problems.
- Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
- Track QA non routine client deliverables and ensure client QA related needs are met
- Provide Quality oversight to internal and external customers.
- Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
- Generate departmental performance metrics for review by management.
- Perform assigned tasks and work to achieve company goals and department objectives by following company policies and procedures.
Other Duties:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Preferred Qualifications:
- B.A. or B.S. degree (preferably in Life Science).
- Minimum of 4 - 5 years of experience in the biopharmaceutical industry at the Associate level.
- Knowledge of cGMPs or equivalent regulations. Ability to interpret Quality standards for implementation.
- Skills to independently evaluate situations and propose potential solutions.
- Able to interpret Quality standards for implementation.
Position Type/Expected Hours of Work:
This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:00 AM to 5:00 PM unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $99,200 - $111,600 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.