Job Details
Posted 20 August, 2026
Job Id: 630252
QA Specialist II
Job Description
Job Description
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations
Key Responsibilities (include but are not limited to):
* To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
* To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.
* Ensure escalation of deviations per procedures
* Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
* Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
* Additional duties as assigned.
* These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Basic Qualifications:
Masters Degree and OR
Bachelors Degree and 2+ years experience in the biological sciences or related field OR
AA Degree and 4+ years experience in the biological sciences or related field OR
High School Degree and 5+ years experience in the biological sciences or related field
Preferred Qualifications:
* Quality Control background in Analytical, Virological, and Microbiological testing
* Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
* Ability to effectively negotiate and build collaboration amongst individuals
* Proficient in MS Word, Excel, Power Point and other applications.
* Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
* Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
Pay Range: 35-42/hr
Based on experience
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.
