Manufacturing Quality Associate / Pharma Industry
Pioneer Data Systems
Thousand Oaks, CA
Temporary, Contractor, Full-time
Thousand Oaks, CA
12 days ago
Our client, a world-leading Pharmaceutical Company in Thousand Oaks, CA is currently looking for a Manufacturing Quality Associate / Pharma Industry to join their expanding team.
- Job Title: Manufacturing Quality Associate / Pharma Industry
- Duration: 12 months contract, extendable up to 36 months
- Location: Thousand Oaks, CA
- The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
- You may participate in the company group medical insurance plan
- Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, Client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship, its operations, or its staff.”
- Must sit onsite, M-F : 7-4 standard hours, however there may be some early or late days that are known ahead of time
- Under minimal supervision, responsible for one or more of the following activities in Manufacturing:
- Analytical testing, characterization, sample and data management
- Equipment maintenance
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within the team.
- Support manual visual inspection of filled units
- This role will support manufacturing operations, as such some extended hours, shift, and weekend work flexibility may be necessary as required.
Specific Job Duties:
- Plan and perform routine analyses with efficiency and accuracy.
- Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
- May perform aseptic aliquoting, sampling and analysis of compendia methods
- Perform accurate laboratory/manufacturing documentation following GMP guidelines.
- With a high degree of technical flexibility, work across diverse areas within the lab.
- Evaluate analytical data
- Perform general lab/area housekeeping
- Maintain/operate specialized equipment
- Comply with safety guidelines, GMPs and other applicable regulatory requirements
- Initiate and/or implement changes in controlled documents
- Troubleshoot, solve problems and communicate with stakeholders
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope
- Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
- May participate in lab/inspection deviation investigations
- May own deviation/CAPA records
- May provide technical guidance
- May train other staff
- May contribute to regulatory filings
- May represent the department/organization on various teams
- May interact with outside resources
- Support manual visual inspection of drug product filled units
- Deepens technical knowledge trough exposure and continuous learning
- Bachelor's degree in Life Sciences & minimum 2 years of biotech industry QC experience/GMP laboratory/manufacturing (preferably in manual visual inspection) experience.
- Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
- Take initiative to identify and drive improvements
- Excellent verbal and written communication skills
- Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Presentation skills
- Escalate issues professionally and on a timely basis
- Decision making skills
- Teamwork and coaching others
- Negotiation and influencing skills
- Project management and organizational skills
- Ability to interact with regulatory agencies
- Data trending and evaluation
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems.
- Ability to work independently and deliver right the first-time results
- Follows procedures.
- Refers to technical standards, principles, theories and precedents as needed.
Top 3 Must Have Skill Sets:
- GMP experience (Preferably in biotech or similar industry)
- Laboratory/analytical background (Preferably in biotech or similar industry)
- Detailed-oriented/Problem solving/Troubleshooting
Day to Day Responsibilities:
- Manual visual inspection operations
- Analytical testing
Employee Value Proposition:
- Chance to gain experience and have high visibility
- No GMP experience
- No schedule flexibility
- Unable to work in a team environment
- Lacking communication skills
About the Company
Pioneer Data Systems
Delivering professional consulting services since 1995. Our original area of focus was providing professional services for Oracle databases. As a market leader, we were recognized as a "New Jersey Technology Fast 50" company by Deloitte & Touche. Pioneer is a certified Minority Business Enterprise (MBE) and a recipient of Inc500 award for America's fastest growing private businesses. Over the years we have leveraged our expertise in the IT space and have diversified across market sectors, now catering to a wide range of practice areas, including Pharmaceutical / Clinical Research, Scientific, Engineering, Accounting and Finance. Many of our clients include Fortune 500 companies that have been trusting us to deliver the highest quality talent for well over a decade. Our strategic offshore location in Pune, India, allows us to take advantage of world time-tables, to offer the highest quality services around the clock. For further information on how our innovative delivery model can enhance your bottom-line, check out section Reduced Cost Per Hire. Our clients can rest assured our dedicated recruiting teams around the globe are committed 24 hours a day to driving forward our mission of acquiring the very best available talent for their staffing needs.
50 to 99 employees