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16 days old

Senior cGMP Compliance Auditor, Oceanside, CA

Kelly Services
Oceanside, CA 92054
**Senior cGMP Compliance Auditor, Oceanside, CA**



**Pay Rate:** $35-40/hour



**Shift:** 1st shift (Monday-Friday; 8am- 5pm)



**Position Type:** On going Temporary role for 3-6+ months



We are seeking an experienced cGMP/Compliance auditor to support on-going internal audit activities in support of Kinovates Master Audit Schedule for 2020. In this role, the qualified auditor will actively and independently conduct internal quality audits for Kinovate in accordance to KLS Quality Management Systems (QMS), policies, SOPs and applicable cGMP regulations and ISO 9001 guidance, as required. Responsibilities for this role include (but may be not limited to) audit scheduling, execution and performance of the scheduled audits covering KLS QMS as required per all applicable regulatory and company requirements. This person will lead several aspects of the internal audits including (but not limited to) planning the audits, writing formal audit plans/agendas, audit checklists, review and collection of all supporting objective evidence and related audit documentation, scheduling/attending pre and post audit meetings with all affected department managers/supervisors/auditees, identifying and documenting all compliance audit issues, immediately informing QA management of any critical audit observations/findings, writing the final audit report with audit summary/findings and submitting the report to QA Management for review/approval. The auditor may be asked to review documentation/objective evidence provided by the auditees in support of audit closure and may follow-up on the audit findings/observations, if necessary.



The auditor shall execute audits for KLS to verify compliance with current Good Manufacturing Practices (cGMP) regulations (i.e. 21 CFR Part 210/211, ICH Q7, ISO 9001), KLS QMS, company policies, procedures and applicable requirements. The incumbent shall bring to the position the necessary auditing skills, training, experience and compliance expertise in support of Kinovates audit program; include and implement all applicable regulatory and company requirements as they apply to the audits performed.



**Under the direction of the QA Manager, the incumbent may be asked to carry out the following additional responsibilities:**




+ Assist other Kinovate team members with their assigned audits as needed or directed by the QA Manager.

+ Assist KLS team members prepare accurate and timely audit reports according to KLS QMS, policies, established procedures and applicable FDA regulations and ISO standards.

+ Perform analyses of audit findings to identify any trends among noncompliance/nonconformity items.

+ Maintain accurate records of all audit findings and activities.

+ Support QA Manager with maintenance of KLS audit program by making sure all audits are up to date by tracking and reviewing KLS Master Audit Schedule.

+ Provide support to QA Manager for all quality-related issues as assigned.

+ Provide training and competency to KLS employees as required/needed.

+ Help create and sustain a culture that is based on continuous improvement of KLS QMS.

+ Conduct remote audits of KLSs critical suppliers and may travel up to 10-15% (after Covid-19 pandemic).

+ Perform other duties as assigned by the QA Manager.



**Basic Qualifications:**




+ Bachelor's degree in life sciences or related discipline with at least 5 years of experience in a Pharmaceutical or Medical Device industry.

+ OR Master's degree in life sciences or related discipline with 3 years of experience in a regulated industry.

+ 3+ years direct auditing experience in a pharmaceutical/medical device industry.

+ Working knowledge of the regulatory environment for the manufacture of pharmaceutical drugs, active ingredients or chemical compound products.

+ Working knowledge and hands on auditing experience against FDA 21 CFR Part 210/211, ICH Q7 Guidance document and/or ISO 9001 standard.

+ Excellent verbal and written communication skills.

+ Must be a team player and work well with coworkers/colleagues at all levels within the company.

+ Excellent interpersonal/communication/influencing/negotiation skills.

+ Detailed orientated w/ good planning and organizational skills.

+ Basic computer skills (i.e. MS Word, Excel, Power Point etc.)



**Preferred Qualifications:** (Not required/mandatory for the position)




+ ASQ Certified Quality Auditor credentials/certificate or comparable online/classroom training w/ reputable organization.

+ Strong analytical and problem solving skills.

+ Experience with Quality Data Trending/Quality Metrics is a plus.

+ Willing to travel up to 10-15% (after Covid-19 pandemic).



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-13 Expires: 2020-12-14

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Senior cGMP Compliance Auditor, Oceanside, CA

Kelly Services
Oceanside, CA 92054

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