Search Jobs
Quality Assurance Specialist
747 Grayson Street Berkeley California USA 94710 Berkeley, CA 94710 US
Job Description
Description: Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records). Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management.
Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.
Skills & Qualifications: (education, experience):
Bachelors degree in a scientific/ technical field.
Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
* Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process. Previous work in Quality Assurance (e.g., release) preferred.
* Proven ability as a team player and leader.
* Excellent interpersonal skills
* Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
* Ability to work both independently and team environment.
* The ability to multitask and support changing priorities
* Strong written and oral communication skills
* Ability to assess, investigate and resolve deviations.
* Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
* In depth knowledge of GMP
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Berkeley, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.