Kelly Services is seeking a QC Investigator in Fenton, MO!
DIRECT HIRE OPPORTUNITY
Location: Fenton, MO
Title: QC Investigator
Department: Quality Control
Function: The Quality Control Investigator, will have the primary responsibility of handling deviations, LIR’s CAPA, OOS etc. in Trackwise. This role will also have the responsibility of maintaining the lab as per GLP.
Primary Responsibilities and Essential Functions of the Position:
- Capable of writing and reviewing deviations, out of specification /lab investigations, and corrective/preventative actions (CAPA) lab investigations utilizing tools like 6M, 5 Why’s etc.
- Responsible for training personnel on CAPA's and deviations.
- Prepare and analyze laboratory analytical trend data
- Participate in internal Audits.
- Implement and manage QC related SOPs and processes. Monitor data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records.
- Manage Site Metrics for QC Lab.
- Write protocols related to Hypothesis testing or other protocol-based activities.
- Ensure a monthly completion of the QC inventory and rejects are transferred to the relevant area (in to Vault for Controlled Substances).
- Ensure the Lab instruments are maintained in a Calibrated state and coordinate with site maintenance team to get the calibrations performed on time.
- Perform Data reviews, as requested by the respective Supervisor.
- Responsible for reviewing changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
- Complete other duties as requested by senior management.
Skills and Abilities Required:
- A fundamental, working knowledge of safety, quality systems, and quality control concepts is required including the application of cGMP.
- Strong understanding of GXP as it pertains to 21 CFR 210, 211 regulated environments, various regulatory bodies and product filing.
- Strong computer skills in database management and documentation preparation (LIMS, SAP, DMS, Trackwise etc.)
- Preference would be given for having at least a 6 Sigma Green belt certification.
- Well with investigation tools like 6M’s and 5 Why’s.
- Technical knowledge of various formulation but not limited to Tablets and capsules.
- Strong analytical knowledge of various instruments but not limited to HPLC, GC, Dissolutions, Wet chemistry etc
- Proficient in MS products including Outlook, Excel, Word and PowerPoint.
Minimum Education and Experience Required:
- Bachelor’s degree
- Pharmaceutical, good manufacturing and warehousing practices preferred
- While performing the duties of this job, the employee is regularly required to stand and sit throughout the workday.
- Ability to lift minimum of 40 lbs.
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
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/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.
Posting ID: 607357942Posted: 2021-02-26