PDS Tech is seeking a Quality Control Associate, in Alachua, FL.
• Independently perform a technical review of data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots.
• Create and revise QC Standard Operating Procedures, Test Records, Stability and Assay Qualification Protocols and Reports to ensure compliance with the requirements of the QC Analytical laboratory and various regulatory agencies.
• Ensure Completion of Periodic/Biennial Review of documents.
• Support investigations (OOS/OOT, deviations, etc), CAPAs, Change Controls, and Planned Variances that occur within the QC laboratory
• As needed, review results and deviations/ investigations from Contract Testing Laboratories (CTLs) as well as our in-house microbiology group.
• Other duties as assigned by supervisor.
• A Bachelor’s degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.
• One to three years of appropriate experience. College coursework may substitute at an equivalent rate for the required experience.
• Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position. QA or QC experience in analytical testing and development is strongly recommended.
Knowledge, Skills, Abilities
• Proficiency with Microsoft office programs such as Word, Excel, and PowerPoint.
• Excellent technical writing and oral communication skills are required.
• Previous experience with Laboratory Information Management Systems and other Electronic Document Systems (eg. Trackwise, Documentum, etc) is recommended.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
• Ability to communicate/work in a high pressure/high paced environment.
• Ability to multi-task and function effectively as a member of a team.
PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:
- Health insurance
- Paid holidays
- Weekly payroll
- Immediate 401(k) eligibility
- Completion Bonuses
- Please note availability of benefits may vary by position
PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com
$$$ PDS pays for referrals! $$$
We pay thousands each month in referral bonuses!
Contact a recruiter for details. To find one near you, take a look at where we are.
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PDS Tech, Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.
If you need special assistance or an accommodation while seeking employment, please click here or call 1-800-270-4737 to contact us. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
The law requires PDS Tech, Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following links: EEO is the Law and EEO is the Law Supplement
PDS Tech, Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information.
As a Federal Contractor, PDS Tech, Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States.
For information please click on the following link: E-Verify