Overview
QA Label Room Inspector – 1st shift Jobs in Piedmont, SC at PL Developments LLC
Description:
BBOT is a private biotech company dedicated to developing innovative new therapeutics to address dire unmet needs in oncology. Founded on a commitment to patients, scientific excellence, and operational agility, we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Driven by a team of experienced scientists, clinicians, and industry experts, our team utilizes cutting-edge structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Ka. BBOT has a pipeline of several promising differentiated drug candidates and strong investor support, the combination of which positions us to deliver meaningful benefit to patients. Our offices and laboratory are in South San Francisco, though our colleagues and collaborators span the country and globe.
Who You Are
Reporting to the Head of Quality Assurance, the Associate Director will assist in the quality oversight and management of GxP activities internally and externally with vendors. The ideal candidate will have extensive quality assurance experience within the biotech/pharmaceutical sector, will be a fast learner and self motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail, and can easily pivot throughout a work day. The ideal candidate should thrive in a busy, fast-paced environment.
Responsibilities
Manages the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release.
Assists in establishing and ongoing management of vendor relationships.
Prepares GxP metric reports and trending for review by management.
Assists in the development and maintenance of GxP SOPs and electronic systems.
Performs other duties as assigned by the Head of Quality Assurance.
Requirements:
Preferred Qualifications
Bachelor’s degree in a scientific discipline or equivalent experience.
Minimum of twelve years industry experience in Quality Assurance, with a minimum of six years within GMP.
Thorough knowledge of applicable regulations.
The annual salary range for this position is $181,000 – $204,000 in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.
Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.
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Title: QA Label Room Inspector – 1st shift
Company: PL Developments LLC
Location: Piedmont, SC
