Quality Assurance Specialist

United Pharma; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

MS Office skills

Job summary

United Pharma is seeking a Lead QA Specialist to manage document control and QA activities under GMP guidelines. You will oversee BPRs, SOPs, RM/AP specifications, and job descriptions, ensuring accuracy and timely updates.

The role requires strong data analysis, CAPA oversight, and collaboration with QA management to drive investigations, audits, and continuous improvement. Excellent communication and attention to detail are essential.

Qualifications

• Bachelor’s degree with 6+ years in QA/related field or an associate’s degree with 10+ years experience.
• Knowledge of cGMP and FDA regulations preferred.
• CAPA/investigation oversight experience preferred.
• Experience collecting, analyzing, and presenting quality data to management.
• Excellent written and verbal communication; strong attention to detail.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM, AP specs, and Job Descriptions.
• Review batch records and analytical results for product release decisions.
• Develop and deliver GMP training programs and services for staff.
• Lead CAPA processes to ensure timely closure and effectiveness.
• Assist in internal audits and participate in customer/FDA audits.
• Provide QA input for product shipments and labeling.
• Generate quality metrics using data systems and Excel pivots.
• Support calibration/maintenance data against quality standards.

Skills

Document control

CAPA oversight

Data analysis

GMP knowledge

Regulatory knowledge

Communication

Project leadership

Team collaboration

Multitasking

English proficiency

Education

Bachelor's degree

Associate's degree

Tools

MS Excel

MS Word

Outlook

MasterControl

Job description

we’re looking for a Lead QA Specialist, responsible for performing duties and functions relative to maintenance of document control of GMP documents in support of Quality Assurance Division functions such as creation of documents, review of analytical data and relative documents, compiling reports, release of material and finished products, tracking and trending quality data, and timely escalation of quality events to management.

Who We’re Looking For

• Bachelor’s Degree with a minimum of 6 years of experience in an applicable field or associate’s degree with a minimum of 10 years of experience in an applicable field.
• Knowledge of cGMP preferred.
• Knowledge of FDA regulations preferred.
• Prior CAPA / Investigation oversight experience preferred.
• Experience in collecting, analyzing, and presenting data and recommendations to management.
• Effective written and verbal communication skills required.
• Proficient in basic applications such as Word, Excel, Outlook.
• High attention to detail.
• Good command of the English language.
• Excellent organizational ability.
• Work collaboratively with others.
• Ability to manage and lead projects assigned by QA Management.
• Able to manage multiple priorities and follow through on projects to completion.
• Ability to work well in a team-oriented environment.

What You’ll Be Doing

• Perform Document Control for Batch Production Records (BPRs), Standard Operating Procedures (SOPs), Raw Material (RM), Avanti Product (AP) specifications and Job Descriptions.
• Conduct product releases/rejections including review of batch production documents, review of analytical results, and comparison to specifications.
• May be tasked with the design, development and delivery of high quality and high impact training programs and services that provide functional, GMP and product knowledge for employees to achieve a high level of performance in their jobs.
• Implement and follow the Corrective and Preventive Action Program (CAPA) process to ensure effective and timely closure of CAPAs.
• Oversight of Facility / Equipment qualification. May be required to help develop and/or review/approve User Requirements Specifications, as well as IQ/OQ/DQ documents.
• Conduct Annual Product Review.
• Provide QA input for product shipments including product release, label preparation, review and application, final label review, shipment packaging, and shipment paperwork.
• Write and revise BPRs, SOPs, RM specs, AP specs and Job Descriptions on a timely basis.
• Perform annual document reviews (when required by quality systems).
• Perform internal audits.
• Conduct raw material qualification and vendor management.
• Prepare for and assist during customer / FDA audits.
• Review / Approve Out-of-Specification (OOS) documentation.
• Perform Change Control (review and approval of Deviations and Change Requests).
• Perform process / method validation program (including design and review of validation efforts).
• May maintain or assist in the maintenance of calibration and maintenance database for equipment to ensure that equipment and instruments are fit for use.
• Keep personal training up to date using Quality Management tools provided.
• Follow all written policies delivered by Management and/or Regulatory Affairs (Standard Operating Procedures, Chemical Hygiene Plan, Emergency Contingency Plan, training memoranda, policy memoranda, Material Safety Data Sheets, Specification Records, etc.).
• Generate quality metrics using specific systems/applications by obtaining raw data, developing quality monitoring database and creating appropriate level reports using MS Excel (pivot tables, charts, graphs, etc.) or other software (MasterControl).
• Perform or participate in investigations using various tools such as root cause analysis, Failure Mode and Effects Analysis, etc.
• Assess causes systemically, looking beyond the obvious to determine why people, processes and/or systems are not meeting quality standards.
• Analyze resulting quality metrics and assess trends.
• Work with supervisors of departments to ensure consistency and close gaps in coaching and training.
• Provide ongoing analysis of data resulting from the quality systems review. Communicate results of analysis to management.