We at Advantage Resourcing are seeking a talented and passionate Scientist I, Formulation for our client in Pleasanton, CA.
POSITION SUMMARY: Manufactures in-vitro diagnostic products (controls and calibrators) used in the clinical laboratory, following cGMP. Completes associated manufacturing documentation and participates in continuous improvement projects. KEY RESPONSIBILITIES:* Manufacture bulk products and perform testing using chemistry clinical analyzers* Completes manufacturing batch records and MPIs, ensure compliance at all times in accordance with cGMP including GDP* Meet on-time delivery dates for each assigned work order and adhere to production schedule* Review and analyze data* Weighing, transfer, mixing of chemicals required* Initiates non-conformance reports as required* Perform product filtrations* Review and approve completed batch records* Maintain and analyze lot histories for trends and discrepancies* Assist with modifying SOPs, work instructions and reports* Recommends improvements to processes, environment or equipment* Participate in daily/weekly lab '5s' activities* Keep department lead or manager updated on all issues* Monitor stocks of common lab supplies* Perform other job duties as required MINIMUM REQUIREMENTS/QUALIFICATIONS:* BS/BA in scientific discipline (chemistry/biochemistry) with 0 - 2 years related experience and/or training preferred. AA degree with 2 - 4 years related experience may be substituted* Experience/understanding of Quality System Regulations and cGMP preferred* Detail oriented, organized, self-motivated and focused* Good verbal and written communication skills* Can follow procedures carefully* Computer/software skills (Outlook, Excel and Word)* Strong laboratory skills including pipetting, safety, and hazardous chemical handling NON-NEGOTIABLE HIRING CRITERIA:* Basic lab skills and knowledge of safety precautions* Must be able to work with potentially hazardous chemicals and human source materials* Must be able to walk and/or stand for extended periods of time* Must be able to lift 25 lbs routinely. May be required to lift up to 50 lbs occasionally This position has not been approved for Relocation Assistance. Job Description
We are looking for innovative candidates to be a key contributor in supporting the development of cutting edge diagnostic methods that will have a direct impact on patient lives. The candidate will support clinical development with primary responsibility for the hands-on management of documentation supporting IVD clinical studies. This candidate will work closely with cross functional development teams to write, edit, review and finalize technical documents required for regulatory submissions of IVD products which includes but not limited to documents for pre-submissions, verification and validation protocols and reports. The secondary role for the candidate is to draft, edit, review and finalize scientific and/or technical documents. The candidate will also review project documentation, assess necessary resources, and estimate timelines for documentation development and review. Knowledge of US and European medical device documentation regulatory requirements would be an advantage. The candidate should have experience with authoring in an agile development environment.
Major Tasks and Responsibilities:
* Coordinating with internal and external experts to organize and maintain documentation pertaining to the life cycle of IVD products.
* Writing, analyzing, and editing user guides, installation guides, and online help systems for future medical devices.
* Collaborates with cross functional team to support successful execution of IVD clinical studies.
* Crafting user-facing documentation based on inputs from cross-functional groups and individuals including, marketing experts, medical experts, regulatory affairs, and product managers.
* Representing the technical writing viewpoint within cross-functional meetings.
* Perform other responsibilities to support the needs of the department as assigned.
* B.S. in a relevant scientific field, such as biochemistry, molecular biology, or cell biology.
* At least 4 years of technical writing experience, preferably in the IVD field and with experience in writing documents for regulatory submissions, such as 510k submissions.
* Experience with drafting, reviewing, editing verification/validation protocols and reports.
* Knowledge of quality and regulatory compliance for IVD product development.
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.