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27 days old

Sr. QA Compliance Specialist

Kelly Services
Tustin, CA 92781
**Kelly Services is currently seeking a** **Sr. QA Compliance Specialist** **for a Direct Hire role in** **Tustin, CA** **.**


**Job Title: Sr. QA Compliance Specialist**


Pay: $110k


**This is a direct-hire salaried position + benefits, PTO, and additional company perks**


The company is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. They provide a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.


We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch.


**Summary** :

As an individual contributor, performs a wide variety of activities to ensure compliance with applicable quality and regulatory requirements by conducting internal and external audits, data and documentation reviews and analysis. Prepares audit reports regarding compliance findings and concerns and provides recommendations for corrective actions. Coordinates resolution of quality issues with suppliers and monitors quality metrics. Writes and revises SOPs. This position focuses on regulatory compliance, strict adherence to the company's quality policy, in addition to improving and implementing cGMP practices.


**Objective** :

Support the Director, Quality Assurance Compliance by conducting internal audits of Operations and Quality Systems and external audits of vendors. Follow up on internal and external audit results to ensure appropriate responses during inspections

Develop solutions to complex issues and Quality initiatives following cGMP regulations

Perform tasks and work to achieve company goals and organizational objectives.


**Essential Duties and Responsibilities include but are not limited to the following** :

Follow company policies and procedures.

Establish work priorities to meet targets and timelines.

Perform independent internal and external audits for adherence to cGMPs and other relevant Federal, foreign and corporate regulations and policies.

Follow up on audit response and corrective actions.

Review data, records and documents to assess appropriateness of investigation, root cause identification and corrective action activities.

Serve as the Quality Compliance representative on cross-functional teams

Identify, design, and implement process and system improvements.

Evaluate regulatory requirement changes, impact to company's operations and make recommendations to management.

Support client audit and regulatory inspection (FDA and Foreign) activities.

Serve as a technical subject matter expert (SME) in support of department functions.

Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.

Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

May conduct investigations related to non-compliance matters.



**Technical Duties/Responsibilities** :

Review and approve quality management records.

Participate in discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed.

Participate in company audit readiness activities.

Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.

Provide guidance to internal and external customers on best practices for maintaining a quality program.

Ensure that the proper policies and procedures are in place.

Identify, design, and implement process improvements.

Provide input into the design and presentation of departmental performance metrics.


This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.


**Qualifications** :

B.A. or B.S. degree (preferably in Life Science) and at least 5-6 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience

Sound knowledge of cGMPs or equivalent regulations

Ability to interpret and relate Quality standards for implementation and review

Ability to make sound decisions about scheduling, allocation of resources, and managing priorities

Ability to communicate clearly and professionally both in writing and verbally

Skillful in problem solving and analytical thinking.

Flexibility in work hours to meet business objectives

Audit skill and/or certification is preferred.


\#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: 2021-09-20 Expires: 2021-10-21

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Sr. QA Compliance Specialist

Kelly Services
Tustin, CA 92781

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