1+ months

Regional QA Lab Manager

Kelly Services
Romeoville, IL 60446
**QA Regional Lab Manager**

Location: Romeoville IL

Salary $85,000

**Job Summary:** The QA Regional Lab Manager will play an active and integral part in the Quality team supporting compliance and improvement for a given region of pharmaceutical facilities approximately 4-5 sites up to 40% travel.

**Essential Duties and Responsibilities:**

+ Ensure compliance to all applicable standard operation procedures SOPs and regulations by implementing an effective and efficient quality management system and maintaining a state of cGMP control for sites within a given region.

+ Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System QMS .

+ Oversee quality-related activities of routine pharmaceutical manufacture and directly supervise site-level Quality Assurance Specialists within a given region.

+ Release clinical and commercial finished product batches, final drug product labels, reagents, manufacturing batch records, QC analytical testing results, and Certification of Analysis for conformance to SOPs

+ Responsible for opening change controls and initiating, maintaining, and reviewing site-specific procedures relative to their job functions.

+ Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites within a given region.

+ Ensure that scientifically sound investigations are conducted, and root causes are identified.

+ Initiate and implement CAPA plans. Evaluate the effectiveness of the CAPA plans through reporting and trending.

+ Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.

+ Monitor and oversee the ongoing training program to qualify the site QASs to follow SOPs to always perform their job functions.

+ Ensure the training covers any newly released procedures, revised procedures, and cGMP updates.

+ Track individuals training requirements and ensure all training is on time and documented.

+ Ensure aseptic operations are in compliance with internal procedures gowning, cleaning/sanitation, sterility, environmental monitoring, etc. , customer requirements, and FDA regulations for sites within a given region.

+ Assure completeness, accuracy, traceability, and compliance of the site s utility and facility monitoring methods and records. Monitor the metrology program for sites within a given region.


+ Bachelors of Science Degree in an appropriate scientific subject (Chemistry, Microbiology, Biology, etc) required

+ 5+ years of work experience in Quality Assurance or Quality Control function required

+ 2 years supervisory experience within a Quality Assurance or Quality Control function

+ Familiarity with pharmaceutical manufacturing processes and related QC release testing preferred.

+ Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards and quality standard attributes.

+ Ability to prepare and present written and verbal reports to upper management

+ Ability to travel up to 40% domestically

For immediate consideration please send resumes in word format to Jenney Tidwell at

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-07-11 Expires: 2022-10-13

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Regional QA Lab Manager

Kelly Services
Romeoville, IL 60446

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