Evaluate and approve manufacturing and packaging documents, along with laboratory test specification records. These documents include both physical copies and electronic batch records (eBR). Ensure that all relevant information is gathered, assessed, and approved before any product disposition.
Identifies improvements/new procedures/ compliance gaps based on applicable regulations.
Assign QA statuses (Release/Reject/Quarantine/Impound) to both work-in-process and finished product.
Investigate and resolve all routine issues that arise during work assignments.
Coordinate all necessary paperwork for batch release.

4-year Bachelor’s Degree in a Science-related field is highly preferred, although relevant GMP Quality experience may be considered as a substitute for the degree.
Candidates should have a minimum of one year of experience in a heavily regulated manufacturing environment, preferably in the pharmaceutical sector.
A thorough understanding of current Good Manufacturing Practices (cGMPs) is essential.
Candidates must possess the ability to perform basic statistical analyses and comprehend AQL sampling plans.
Proficiency in computer applications, including Veeva, eBR, MS Office, and other relevant software is required.
The ability to read, interpret, and adhere to instructions in English, including SOPs, batch records, and cGMPs, is necessary.
Clear and concise communication skills are important for effectively conveying information, summarizing details, and asking questions.
Experience collaborating with cross-functional teams such as planning, manufacturing, packaging, and distribution is crucial to ensure that priorities are established and activities are organized to achieve objectives.
This position may involve prolonged periods of standing, walking throughout the facility, and lifting items weighing up to 25 pounds.

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Quality Analyst I

Key skills