Quality Assurance Engineer

Quality Engineer leads efforts in site quality assurance programs and improvement activities.

He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements.

The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.

Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program.

He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

We need QA candidates who have owned manufacturing investigations end to end, not supported them.

Must-have experience:

5+ years Quality Assurance (QA, not QC)

GMP deviation and manufacturing investigations ownership, not "assisted with "

CAPA management including effectiveness checks

Root cause analysis with named methodology (5 Whys, Fishbone, FMECA)

Customer complaint investigations frequently missing; direct customer interaction preferred

Internal audits and ISO 9001

Change control

Validation support (process, cleaning, IQ/OQ/PQ)

Pharmaceutical or chemical manufacturing environment

Also valued

Hosting customer, certification, and regulatory audits

Statistical evaluation and process trending (SPC)

Delivering GMP/GDP training to site personnel

Supplier quality collaboration

Education

BS in Chemistry, Biology, Biochemistry, Chemical Engineering, or Microbiology preferred. Pharmacy (B.Pharm) and related science degrees will be considered where QA experience is strong.

Pharmaceutical manufacturing, biotech manufacturing, chemical manufacturing, reagent/life sciences. Medical device as a secondary option.

Pride Global and it's affiliates offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Pride Global and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Pride Global and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates:
Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.