Location: Hercules,CA, USA
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Job Type
Full-time
Description
Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!
PBL has immediate openings for full or part time Document Control Specialist I in the Quality Assurance Department. The general responsibility of the QA Document Control Specialist I assisting Quality Management in administering the company's systems for document control. A large part of the Document Control Specialist's job consists of maintaining the company's Operations Procedures and the company's Form/Worksheet Control System. Overall, the Document Control Specialist role presents the employee with an opportunity to contribute substantially to the company's ongoing success as a quality testing laboratory.
PRIMARY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
* Under the direction of the Quality Management, maintain the company's Site Standard Operations Procedures. This includes word processing and other applicable software SOPs, routing SOPs for routine review, maintaining a current index for each section of the Manual, assigning numbers to new SOPs, publishing and approving SOPs into the appropriate department folders, routing SOPs, and assisting in archiving SOPs.
* Assist Quality Management in maintaining the company's Form/Worksheet Control System. This includes assigning numbers to new forms/worksheets, assigning revision codes to revised forms/worksheets, and copying and filing forms/worksheets into the appropriate department folders.
* Assist Quality Management in assigning, tracking, and bringing to closure Revision Requests.
* Assist in managing and controlling Client methods.
* Assist if needed in managing Quality Agreements and other legal documents including Non-disclosure and Service Agreements.
* Compliance with GMP/GLP and ISO requirements as these pertain to document control.
* Knowledge of and familiarity with all SOPs pertaining to the company's document control functions.
* Other duties as needed.
Requirements
QUALIFICATIONS:
* High School Diploma or equivalent
* Excellent organizational skills
* Strong communication skills
* Knowledge of pharmaceutical and/or medical device regulatory requirements expected (GLP, GMP, GCP) beneficial
The pay range for this position is $ $55,000 - $63,000 paid on hourly basis excluding overtime. The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.
PM21