QA Associate 3rd Shift - Pharmaceutical Industry
Company: ASCENDING Inc.
Location: Chantilly
Posted on: January 21, 2023
Job Description:
Description
JOB DUTIES & RESPONSIBILITIES
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 SOP's, state, federal and local laws as applicable.
Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
- 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, SOP's. 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
Reports to
Quality Compliance manager
Physical Requirements/Working Environment
- While performing the duties of this job, the employee is
regularly required to, stand, sit, talk, hear, and use hands and
fingers to operate a computer and telephone keyboard.
- Specific vision abilities required by this job include close
vision requirements due to computer work.
- Ability to sit at a computer terminal for an extended period of
time.
- Light to moderate lifting up to 10-15 lbs is required.
- Ability to work in a confined area.
Benefits:
- 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
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
Company has an extensive list of initiatives implemented for
employees health and overall safety in response to the COVID
pandemic to ensure safe optimal working conditions for our
personnel.
Requirements
Qualifications
- Manufacturing: 2 years (Preferred)
- Document management: 2 years (Preferred)
- Quality assurance: 2 years (Preferred)
Knowledge & Skills
- 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.
- Multiple priorities and re-prioritize tasks.
Experience & Education
- At least two (2 years) to three (3) years of experience in a
quality assurance role in a cGMP-regulated environment.
- A college Degree preferably in sciences (i.e., Biology,
Chemistry etc.)
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Keywords: ASCENDING Inc., Chantilly , QA Associate 3rd Shift - Pharmaceutical Industry, Healthcare , Chantilly, Virginia
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