Quality Assurance Senior Associate, Biopharma; JP

Position: Quality Assurance Senior Associate, Biopharma (JP10382)
Job Title:Quality Assurance Senior Associate, Biopharma (JP10382)
Location:Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit:Drug Product Quality Assurance
Duration:12 months with likely extensions
Rate
: $28-32/Hr W2.
Posting Date:06/07/22

3 Key Consulting is hiring a
Quality Assurance Senior Associate
for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.

Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

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.
• Experience managing projects through to completion meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems Strong organizational skills and ability to manage multiple tasks at one time Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives.
• Solid understanding and application of aseptic behaviors and principles

Basic Qualifications:
Master's degree and 1 years of Quality experience OR
Bachelor's degree and 2 years of Quality experience OR
Associate's degree and 6 years of Quality experience

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:

• Must have Pharma industry experience
• Experience in manufacturing or quality fields within biotech or pharma industries.
• Complex decision making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.
• Technical writing skills
• The ideal candidate would have applicable drug substance/drug product bio-tech manufacturing facilities as a QA or from a manufacturing background

Day to Day Responsibilities:

• The role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems.
• Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Employee Value Proposition:
The person in this role will oversee a drug product facility and interacts with different departments outside of manufacturing

Red Flags:
Minimal to no experience

Interview process:
Phone screening followed by panel interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr