Title : MCS Associate Quality Control
Contract : 6 Months
Location : Thousand Oaks, CA
100% onsite
Shift / Schedule - 8 : 00 - 5 : 00 pm
Ideal Candidate :
- Candidates must have an educational background in Chemistry or Biology, along with experience in GMP within the biotech or pharmaceutical industry, with a focus on pipetting techniques.
- A minimum of 2 years of GMP experience is preferred.
- Proficiency in software tools such as Teams, Excel, and Word is essential.
- Familiarity with SharePoint, SmartSheets, or LIMS is a plus.
- Strong communication skills are also a key requirement for this role.
Intake Notes :
Top 3 Must Have Skill Sets :
- Pipetting
- Influential leadership and project management skills to drive teams to meet project milestones
- Very organized in thinking, ability to coordinate multiple tasks and deadlines and through collaborations assign deadlines and accountability with internal and external partners
- Detail oriented, self-motivated, and ability to pro-actively manage tasks and identify improvement opportunities
Day to Day Responsibilities :
- Verifies an instrument's ability to meet its manufacturer's design specifications
- Follow all safety guidelines
- Maintain equipment
- Order and stock lab supplies
- Logging data
- Maintain a Safe working environment
- Clean and sanitize lab equipment
Summary :
Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of the following activities : - Performing routine laboratory procedures - Routine analytical testing - Documenting, computing, compiling, interpreting, and entering data - Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents.
Must learn and comply with safety guidelines and cGMPs / CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.
Job Responsibilities
- Responsible for one or more of the following activities in QC : analytical testing, sample and data management and equipment maintenance.
- Perform routine laboratory procedures such as sample analysis, standard and solution preparation.
- Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.
- Providing and communicating results, maintaining / operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
- Support introduction of new methods / techniques into the lab.
- Perform basic assay and instrument troubleshooting.
- May identify, recommend and implement improvements related to routine job functions.
- Must learn and comply with safety guideline and basic cGMPs
- Must be flexible in working schedule as required
- Must be able to be on-call for CEMS as required
Preferred Qualifications
- Bachelor degree and 2 years of Quality Control, Quality Assurance OR related experience OR Associate degree and 6 years of Quality Control, Quality Assurance OR related experience OR High school diploma / GED and 8 years of Quality Control, Quality Assurance OR related experience
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation / data according to company and regulatory guidelines
- Ability to organize work, handle multiple priorities and meet deadlines
- Strong written and oral communication skills
- Must be detail orientated
- Must be flexible and adaptable to changing priorities and requirements
- Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
- Demonstrates understanding of when and how to appropriately escalate.
- May identify, recommend and implement improvements related to routine job functions.
- Must learn and comply with safety guideline and cGMPs.