QA Technician; 2nd & 3rd Shift

Overview

The QA technician ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOPs, state, federal and local laws as applicable.

• Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
• Collaborate with team members and site customers to ensure timely deliverables for documentation.
• Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
• Management of quality documentation which includes but is not limited to number issuance, logbooks and spreadsheets.
• Review of batch records and equipment logbooks.
• Issue batch records, SOPs and protocols as needed.
• Assist in scanning of documents as needed.
• Collect purified water and environmental samples and trend results.
• Perform weekly floor audits for manufacturing.
• Perform swab sampling or cleaning validation and/or verification.
• Ability to be flexible with working hours and weekend coverage when needed.
• Any other activity as assigned by the Supervisor.

QA Lead/Manager

• Regularly required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
• Specific vision abilities required due to computer work.
• Ability to sit at a computer terminal for extended periods.
• Light to moderate lifting up to 10-15 lbs.
• Ability to work in a confined area.

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Required Qualifications:

• Quality assurance within Pharmaceutical Industry: 2 years
• Manufacturing: 2 years (Preferred)
• Document management: 2 years (Preferred)

• cGMP compliance within the pharmaceutical manufacturing industry.
• Writing and maintaining cGMP documentation.
• Analyze data/information and resolve complex issues.
• Verbal and written communication skills.
• Work and communicate with cross-functional teams.
• Ability to manage multiple priorities and re-prioritize tasks.

• At least 2-3 years of experience in a quality assurance role in a cGMP-regulated environment.
• A college degree preferably in sciences (e.g., Biology, Chemistry) or related discipline.

Location:

Gaithersburg, MD

Salary: $60,000 - $75,000