Team Lead, Quality Control- Stability - Vista, CA | Biospace
Get Our FREE Industry eNewsletter

Team Lead, Quality Control- Stability

Bachem

Apply
Location:
Vista, CA
Posted Date:
11/17/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Quality Control,

Job Description

•   Experience operating a variety of analytical equipment (e.g. HPLC, UPLC, Karl Fischer, etc.)
•   Maintain and perform daily operations of the QC Stability program on a daily basis in coordination with the QC Director/Supervisor to include stability testing of peptide samples and prioritizing projects
•   Implement and maintain GMP procedures such as following SOPs, STPs, written procedures and maintaining proper documentation as necessary for Quality Control stability testing program
•   Test and review stability data for stability reports of peptide stability samples for stability program. This includes performing analyses and reviewing data for completeness and accuracy.
•   Maintain a cGMP quality level of work for the QC Stability Program to include training documentation and procedural work.
•   Write and maintain applicable SOPs. Write/revise specifications as necessary.
•   Provide analytical support to other functions of Quality Control, Purification and Synthesis, as applicable
•   Coordinate testing activities with other QC Scientists for meeting stability timelines.
•   Maintain the stability chambers and stability inventory for stability program.
•   Review laboratory notebooks, logbooks, protocols and reports, as applicable
•   Investigate any deviation or out of specification as necessary related to QC stability testing as instructed by supervisor
•   Assist management during inspections and internal audits
•   Work with clients to include teleconferences/meetings, exchange of data/information for stability program
•   Schedule use of equipment and coordination of instruments with other QC scientists, as necessary
•   Follow safety guidelines for handling, disposal of toxic and / or large volumes of chemicals

Requirements

Required:

•   BS degree in Chemistry, Biochemistry or related discipline
•   Over 8 years’ experience in the pharmaceutical or biotech industry
•   Use of analytical techniques / instruments, such as HPLC, KF, GC, etc., and computer skills is highly desirable.
•   Knowledge of ICH Q1 and ICH Q7, cGMP and FDA regulations
•   Ability to effectively organize, multitask, and work in a fast-paced environment
•   Excellent written and oral communications skills
•   Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
•   Exhibit professional interpersonal skills
•   Communicate effectively and ability to function well in a team environment
•   Exhibit detail oriented documentation skills
•   Ability to work independently and manage one's time
•   Basic computer knowledge, including Microsoft Word and Excel
•   Coordinate testing activities with other QC Scientists for meeting stability testing schedules.
•   Maintain the stability chambers and stability inventory for stability programs.
•   Ability to convey to customers and regulatory agencies the stability program rationale and status
•   Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

PREFERRED:

•   Master’s degree in Chemistry or related discipline
•   Experience with peptides