JobWatch

1+ months

Director of Quality Assurance

Kelly Services
Temple, TX 76504
**Job Title: Director of Quality Assurance**


**Location: Temple, TX**


**Work Type: Direct-Hire, Full-Time, On-Site**


**Position Overview:**

Responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the supervisor over the QA and QS staff, coordinating roles & responsibilities and projects.


**Responsibilities may include:**

Supervises QA & QS managers by providing learning and development where appropriate

Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations

Manages the on-time release of batches

Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation

Manages others to ensure appropriate SOPs and training documents are in place & effective

Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place

Manages others to ensure quality standards are met at the site so that processes are the same as other sites

Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities

Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products

Manages the design and implementation of site policies and procedures

Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements

Promptly communicates with Operations regarding complaints, product issues/variances

Enforces applicable personnel policies and procedures

Other duties as assigned


**Qualifications:**

Legally authorized to work in the job posting country

Bachelors Degree in Life Science or other related field

Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry

Minimum 5 years of supervisory or management experience required

Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products

Technical writing and communication

Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMPs and have demonstrated strength in problem solving and resolution

Strong interpersonal skills


**_For immediate consideration apply today!_**


**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.

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Posted: 2022-08-10 Expires: 2022-10-10

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Director of Quality Assurance

Kelly Services
Temple, TX 76504

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