An employer in the lab consumables/disposables manufacturing industry is looking for a Sr. QA Specialist or Quality Assurance Manager to join their team. This role involves laying out policies and procedures, with 50% of the time spent at the manufacturing site in Oceanside, only 8 miles away. The individual will interface with customers regarding regulatory and compliance issues, collaborate with other groups, including the QC Manager and Supervisors, and serve as the internal auditor leading audits. Additionally, they will champion the development of other individuals to achieve internal auditor certification. The role will also include responsibilities related to new product development from a QA perspective, customer-related issues, and managing customer surveys/questionnaires, ensuring that responses are communicated effectively. Contributing to the ISO certification of the Oceanside site is also a key focus, as most customers are GMP companies, primarily in the pharmaceutical sector.
Some responsibilities of the Sr. QA Specialist or Quality Assurance Manager will include but are not limited to:
- Laying out policies and procedures
- Customer interface regarding regulatory and compliance
- Leading internal audits and championing internal auditor certification for others
- Collaborating on new product development processes
- Handling customer complaints and investigations
- Responding to GMP customer surveys/questionnaires
- Championing the 8D investigations and communicating responses back to the customers
- Contributing to the ISO certification process for the Oceanside site
LOCATION/TRAVEL:
- 50% Carlsbad, CA and 50% Oceanside, CA (worksites are 8 miles apart)
SCHEDULE:
- Monday - Friday
- 8:00 AM - 5:00 PM with occasional exceptions
TRAINING:
- On-the-job training will be provided to familiarize with company-specific policies and procedures. Ongoing education for employees will also be a part of the role's responsibilities.
IMPORTANT TO NOTE:
- This is a small, family-owned business with 100+ employees; candidates should be prepared to roll up their sleeves and work collaboratively with limited support. A strong personality with confidence and presentation skills is essential for success in this role.
COMPANY/POSITION HIGHLIGHTS:
- Work environment in a small organization with 100+ employees focused on collaboration and hands-on involvement.
- Opportunity for professional growth and education within the quality assurance field.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
[email protected].
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- Senior: 3 - 5 years' experience within QA in life sciences
- Manager: 5 7+ years' experience within QA in life sciences
- Experience in ISO 9001:2015 environment; familiarity with ISO 13485 (medical device standards) is preferred
- Proven experience performing internal audits and engaging effectively with customers/auditors
- Experience in 8D problem-solving methodology
- Internal auditor certification is a significant advantage
- Bilingual in Spanish
- Background in GMP or GxP environments is preferred
- Preference for candidates who have advanced through the ranks in their career
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.