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20 days old

Quality Compliance Specialist III

Kelly Services
Brooklyn Park, MN 55443
Kelly is hiring a **Quality Compliance Specialist III** for one of our biotech clients in **Brooklyn Park, Minnesota**


+ 6 months to start off

+ Brooklyn Park role; local candidates only

+ Hybrid work model- on-site and remote flexible

+ $40-$46/hr


**OBJECTIVES:**

Support Quality Compliance activities associated with Commercial cGMP biologics drug substance operations through internal/regulatory body audits, document review and interactions with site personnel at Takeda Brooklyn Park site.

Support site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.


**ACCOUNTABILITIES:**

Regularly work cross-functionally with other departments and may also interact with other Takeda sites and/or Brooklyn Park suppliers to ensure global compliance and consistency.

Support application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.

Support analyses of manufacturing-related quality metrics to identify risks, improvement opportunities and/or compliance concerns. Support resolutions to conclusion by supporting continuous improvement initiatives.

Support logistic activities related to the Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.

QA support on corrective actions resulting from self-assessments or inspection readiness activities.

Support during all internal or regulatory audits/inspections of Quality & Operations departments.

Perform weekly monitoring and updates to quality systems for any adverse compliance trends and escalate any risks to manager.

May identify regulatory issues and trends and escalate to manager, as appropriate.

Receives minimal supervision on routine work assignments. Receives specific instruction on new work.

Complete mandatory training within required timeframe.

Additional tasks and duties as assigned.


**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:**

Bachelors degree in Life Sciences and 3-5 years experience in a regulated industry preferred.

Masters degree in Life Sciences with 0-2 years experience in a regulated industry a plus.

Knowledge of cGMP regulations for US, EU and other markets.

Must be detail-oriented and have effective time management skills.,.

Excellent interpersonal skills and the ability to work effectively and efficiently in a team environment.

Must be able to clearly and effectively present to all levels of the organization

Excellent organizational skills

Proficient computer, verbal and written communication skills.

Strong problem solving and data analysis skills.

Drives results


**PHYSICAL DEMANDS:**

In general, the position requires a combination of sedentary work and walking around the facility.

Frequent wrist and hand motion (e.g. typing, writing).

May frequently lift up to 10 pounds (i.e. binders, files)


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-30 Expires: 2021-09-30

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Quality Compliance Specialist III

Kelly Services
Brooklyn Park, MN 55443

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