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15 days old

Quality Assurance Manager

Kelly Services
Albany, OR 97321
**Quality Assurance Manager**


Kelly is looking for a Quality Assurance Manager for a World Class, purpose-driven technology solutions company with nearly six decades of freeze-drying expertise. This position is responsible for governance of the companys six system. The Quality Compliance Manager will develop partnerships with key enterprise business partners, stakeholders, and customers to advance solutions and enable transparency, escalation, and resolution of quality and compliance matters. This requires fostering openness and collaboration to achieve goals within the appropriate risk-mitigating environment.


**Specific duties and responsibilities:**

Plans, implements and ensures an effective quality program, with support of upper management.

Ensure all activities/measures related to the approved procedures and specifications are in place for the six systems: Quality, Production, Facilities/Equipment, Laboratory, Materials, and Packaging.

Approves all procedures (SOPs, calibration, MPs) and specifications for activities and measures for all six systems.

Audits manufacturing practices and processes for compliance to all customer and regulatory requirements.

Leads complaint reviews/responses in a timely manner, including corrective/preventive action(s) where appropriate.

Assists with and finalizes reporting on discrepancy and failure investigations related to manufacturing and testing.

Oversees investigation, disposition, and communication of rejected material(s)/component(s).

Oversees content and audits the adherence to cGMP training/qualification of manufacturing employees.

Assists with/approves analytical method development/validation protocols.

Hosts regulatory agency and customer audits of OFD Quality System.

Supports development and clinical project onboarding, advising on transfer to commercial production.

Reviews/approves all protocols for facility, equipment, process, material testing, and analytical method development.


**Qualifications:**

Bachelor's degree in Microbiology, Chemistry, Biochemistry or related field.

Minimum three years experience within the quality sector.

Understanding of statistical analysis methods and applications.

Demonstrated experience working with cross-functional teams on projects affecting multiple departments.


+ Growing company in branded, contract services and bio/pharma products

+ Medical, dental, vision, and life insurance available 1st of the month following 30 days from hire

+ PTO and holiday pay available upon hire

+ Incentive bonus (target of 10% to be paid annually)

+ Tuition assistance

+ Growth and advancement opportunities

+ Employee discount on Mountain House products

+ Great culture, team work and continuous improvement awareness


\#P1


**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: 2022-09-21 Expires: 2022-10-24

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Quality Assurance Manager

Kelly Services
Albany, OR 97321

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