Quality Document Control Specialist - Anaheim, CA
Job Duties and Responsibilities:
- Manages and process DCRs, & SOPs. Track revision history.
- Reviews documentation to assure accuracy and completeness.
- Maintains files and data archiving of controlled QA documents.
- Maintains documents in accordance with department SOPs. Analyzes all documents to ensure that controls regarding format and content are incorporated.
- Maintains database of information including all document numbers, dates and distribution requirements. Generates logs, indexes and distribution lists as required. Assures that all documents are reviewed for continuing compliance to cGMPs and company policies on a periodic basis.
- Processes change control activities includes assigning tracking numbers, routing, tracking, and expediting change control packages, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
- Maintains Quality documents, including, but not limited to, Reports, COA, Batch Records, training, test methods, forms and other supporting documents.
- Issues, but not limited to, batch records, logs, forms and other documents as requested or as scheduled.
- Tracks the issuance of deviations, CAPAs, NCMRs, OOS, Complaints
- Coordinates in-house training for new and revised documents as required. Maintains hard-copies and electronic database of all employee training records.
- Recommends corrective actions for quality issues.
- Ensures daily work flow completion.
- Assist on timely release of finished goods.
- Assign control number to change requests.
- Assist in the monitoring and record keeping of pest control activities.
- Assist in the validation and verification efforts.
- Coordinates destruction of expired products and records.
- Assist in preparation for customer audits and regulatory inspections.
- Degree preferred but not required (AS / BS), experience is preferable.
- Two (2 ) year work related experience in document control within food, pharma, nutraceutical, or related field.
- Working knowledge of cGMPS and FDA regulations , Microsoft Office suite familiarity, and strong data entry skills.
- Knowledge of 21 CFR part 111
- Knowledge of G.F.SI. certifying bodies such as N.S.F., Organic Certifications, etc)
- 2+ years operating in Quality in a cGMP manufacturing environment, preferably under 21 CFR 111.
- Proficient in Microsoft Word & Excel
- Proficient in GDPs including reviewing Batch Record Documentation for Compliance.
- Familiarity with reviewing test results
- Maintaining files according to SOPs and applicable agency compliance.
- Maintaining, reviewing, and Filing cGMP documentation including: batch production and packaging records, standard operating procedures(SOPs), technical reports, logs, and
- calibration records
- Experience with Standard Operation Procedures (SOPs)
For immediate consideration, apply today! Questions? Contact Toni at 714.454.8252 OR TONM369@kellyservices.com
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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