Job Description

Overview

This position supports the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations. Responsibilities include evaluation of compliance issues, providing recommendations, and ensuring quality records to completion. The Sr. Associate will also represent a functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Responsibilities

• Purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• The Sr. Associate will also represent the functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Requirements

• The ideal candidate f will have 1-2+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries.
• While a bachelors degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, highly cross-functional environment.
• This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately.
• Candidates seeking long-term opportunities with potential for FTE conversion will be prioritized; this is not intended for short-term or transitional job seekers.
• Fresh graduates without industry experience will not be considered.

Preferred Qualifications

• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
• Ability to make quality-based decisions to ensure compliance.
• Experience managing projects to completion and meeting timelines.
• Experience evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems; strong organizational and multi-tasking abilities; effective written and verbal communication.
• Demonstrated ability to work as both a team player and independently; leadership attributes and drive for improvement initiatives.

Top 3 Must Have Skill Sets

• Flexibility on shifts
• Attention to detail
• Quality background

Pay

Base pay range: $30.00/hr - $32.50/hr.

Payrate: $30.00 - $32.50/hr.

Pay Transparency: The typical base pay for this role across the U.S. is $30.00 - $32.50/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

Job details

• Seniority level: Entry level
• Employment type: Contract
• Job function: Quality Assurance

Location: Thousand Oaks, CA

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