JobWatch

1+ months

Quality Control Manager

Kelly Services
College Station, TX 77840
**Kelly Services is actively recruiting for a QC Manager for Direct Hire in College Station Area, TX.**


Summary: The Quality Control Compliance Manager leads the tracking, coordination, and closure of Quality Controls CAPAs, change controls and deviations. The successful candidate will also assist the QC department in OOS/OOT investigations. The candidate will ensure all PRs and change controls are closed out in a timely manner.


Essential Functions:


+ Work closely with QC Managers and Quality Assurance to ensure all QC deviations and CAPAs are written appropriately and contain all relevant information required to meet department, company, and regulatory requirements. Work collaboratively with site management to instill a Quality Culture by coaching Quality Control staff in the application of GMP Principles including the underlying rational of those principles.

+ Responsible for leading OOS / OOT investigations, assist in authoring hypothesis and retest plans.

+ Support the Quality organization during compliance and Due-Diligence audits, assist in preparing audit responses and ensure responses are actions are implemented within the given time frame.

+ Support the internal Audit Programs to ensure the QC Department is in a state of compliance

+ Work with Quality management to implement and strengthen Quality Systems that will enable cGMP release and stability testing of pre-clinical to commercial products

+ Responsible for QC audit preparations, to include but not limited to: log book review, training record review, compliance wire review. Assist QC managers conducting internal Departmental audits. Coordinates the initiation of new deviations.

+ Initiate and leads deviation, CAPA, and change control closure for Quality Control

+ Leads Root Cause Analysis Investigations

+ Attend customer meetings to provide investigational updates as needed.

+ Establish and maintain metrics around deviations, CAPAs and change control status.

+ Assist QC Managers in reviewing protocols, reports, testing data and SOPs as needed.

+ All other duties assigned


Required Skills & Abilities:


+ Excellent oral and written communication skills, interpersonal and organizational skills.

+ Excellent organizational, analytical, data review and report writing skills

+ Proficient with Microsoft Office applications.

+ Good self-discipline and attention to detail.

+ Ability to multitask and easily prioritize work.

+ Ability to work independently with little supervision.

+ Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.


Working Conditions & Physical Requirements:


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:


+ Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.

+ Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

+ Lift up to 25 pounds frequently and up to 50 pounds, on occasion.

+ Attendance is mandatory.


Qualifications:


+ Bachelors Degree with a minimum of 5 years working in a GMP environment

+ Experience authoring CAPAs, change controls, and deviations


Preferred Qualifications:


+ Experience working in a Quality Assurance role, batch record review, analytical data review


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


TJP2021_SPEC


**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)
Posted: 2021-08-27 Expires: 2021-10-28

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Quality Control Manager

Kelly Services
College Station, TX 77840

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