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Document Control Manager

Location:
Rosemead, CA
Posted:
December 02, 2016

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Resume:

Andy Leung

**** *** *** *** *** B, Rosemead, CA *1770

Cell Phone: 626-***-****

Email: acxqo8@r.postjobfree.com

OBJECTIVE

To obtain a Document Control/Technical Writing position in the pharmaceutical, biotech, or related industry

EDUCATION

M.B.A., International Business, University of the West, Rosemead, CA, (January 2015)

B.S., Biochemistry and Cell Biology, University of California, San Diego, CA, (June 2005)

RELATED EXPERIENCE

Document Control Technical Writer, Gilead Sciences, Inc., San Dimas, CA (11/2015-Present)

Responsible for planning, developing, organizing, info-mapping, writing, formatting and editing operational procedures and manuals for the QA, Manufacturing, and Supply Chain departments during the Kaizen projects.

Recommend and incorporate process improvements or changes to the drafts of the SOPs involved in the Kaizen projects.

Take new pictures to demonstrate the process improvements or changes.

Reorganize and reformat the technical specifications, pictures, flowcharts, figures, forms, and other attachments as needed.

Update and incorporate the critiques and changes from management into the final drafts.

Acquire and organize source SOPs from the GDocs and GDocs DocLibrary.

Create and maintain document templates.

Check format and conformance to document templates, and verify own work.

Review and reformat the controlled documents according to the QA document control templates.

Create and submit change requests (CR) for document revision or obsoletion.

Change business owners for effective documents.

Review and check for missing entries for log books.

Provide additional support and assistance on tasks and projects as directed by management.

Technical Development Specialist, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA (08/2012-11/2015)

Prepared drug submission materials of new products for regulatory approval, including NDA, ANDA, DMF, IND.

Provided literature search/scientific information to the Company’s new projects under supervision.

Wrote scientific research papers about epinephrine inhalation to support the drug submission.

Organized hard copies and e-files of documentation for drug submission to FDA.

Uploaded e-files in eCTD systems for drug submission.

Communicated with inter-departments for collecting clinical data and attachments.

Prepared and generated Clinical Study Report in writing for new drug submission to FDA.

Reviewed, revised, and generated SOPs for clinical and non-clinical related procedures as needed.

Provide support for investigation and CAPA documents.

Assisted in providing document support to the improvement of the Company existing operational systems, including SOP revision, job description revision, administrative handbook revision, etc.

Provided document support in translation of SOPs for the Amphastar France Pharmaceuticals facility.

Product Specialist, Amkey, Inc., Irwindale, CA (08/2010-08/2012)

Researched on FDA regulations 21 CFR regarding health claims for dietary supplements.

Reviewed and revised the health claims on all of the Amkey’s products.

Worked with GMP certified contract manufacturers to resolve quality issues regarding the products.

Answered technical questions regarding health products.

Maintained good relationship with customers, branch staffs, and contract manufacturer executives.

Analyzed and interpreted test results from the contract laboratory.

Prepared and organized documents for product export and registration to other countries.

Helped to research on marketing plans and make suggestions on developing new products.

QC/QA Chemist, Laclede, Inc. (Biotene dental products), Rancho Dominguez, CA (12/2005-08/2010)

Performed identification tests and analytical assays on raw materials, in-process and finished products, and stability samples by following the in-house SOPs or USP reference.

Conducted analytical assays by using HPLC, FTIR, Ion Chromatography, UV spectroscopy, pH meter, specific gravity meter, balance, titration machine, viscosity meter and melting point apparatus.

Reviewed data obtained for compliance to specifications and reported abnormalities if any.

Compiled data for documentation of test procedures and preparation of reports.

Revised and Generated SOPs as needed.

Investigated and resolved issues related to assay failures, system deficiencies, OOS, deviations.

Generated and maintained CAPA and NCR per SOP or Manager's instruction.

Maintained, calibrated, and troubleshot independently or as part of a team.

Ordered supplies for the lab in a timely manner to support the workload.

Reviewed peer data and lab notebooks.

Helped to train entry level analysts.

Issued, maintained, and reviewed laboratory notebooks, equipment calibration and maintenance log books, and batch records.

Communicated and cooperated with production, warehouse, and packaging departments.

Played an active role in the preparation and maintenance of the lab for audits.

Applied knowledge of cGMP, GDP, and GLP on daily basis, as well as followed the actions and rules of all compliance programs.

SKILLS/QUALIFICATIONS

Able to follow detailed operating procedures and protocols with minimal supervision.

Able to learn and handle new tasks quickly.

Able to work effectively in a team environment as well as independently.

Able to work in environment under cGMP, GDP, GLP, and FDA requirements.

Organized and detail oriented.

Excellent oral and written communication skills.

Computer: Able to operate Macintosh and Windows systems; Proficient in Microsoft Word, Excel, PowerPoint, Outlook, JMP, internet, email, researching the internet and knowledge of hardware and software; Keyboarding 45 wpm with ten key skills.

Languages: Fluent in English, Cantonese, and Mandarin (read, speak and write).

REFERENCES: Available upon request.



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