What are the responsibilities and job description for the QA Specialist (Batch Record/SAP/21 CFR) (Pharma/Medical Device) position at Systems Ally?
100% Onsite
No extension guaranteed
Major part of the job is batch release & marketing authorization activities
High School diploma with 3-5 yrs exp needed
Bachelors degree with 2 yrs exp needed
Masters degree will also work
Bachelors or masters degree with 5-7 yrs will also work
Pharma exp with GMP exp will be preferred
Industry experience needed
- Pharma regulations will also be helpful
- Supporting global activities
- Knowledge of 21CFR needed
- Help manage some marketing authorization activities
- Perform batch release activities
- Work on QA activities
- Reviewing documentation
- Role is heavily based in SAP
- Collaborative
- EU regulation background will also be beneficial
- Critical thinking
Top skills
- 21 CFR regulation
- Batch release
- Marketing authorization topics
- SAP highly preferred
Assignment will last until the end of the year. Most likely will not be extended
- Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.
- Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.
- Approve/initiate changes to Distribution Operations and QA procedures, facility and equipment
- Audit Interface- FDA, supplier, customer inspection, corporate
- Conduct product quality, diversion and distribution complaint investigations
- Manage warehouse temperature monitoring program
- Initiate exceptions reports in the appropriate database
- Perform inbound quality inspections and usage decision
- Execute domestic and international sales/recall reports
- Execute placement and removal of QA Holds in warehouse management system
- Manage/Post supplier audit data in appropriate database
- Manage market authorization process and Material Data Management
Qualifications
- High school degree is required.
- Bachelor’s degree is preferred
- 2-4 years in Quality Assurance, Process Support, Manufacturing, Distribution, Quality Control or similar area.
- Reviewing problem solving situation
- Understand manufacturing / distribution process
- Product responsibility for compliance troubleshooting
- Audit interface
- Creativity in resolving issues
- Negotiation skills with Mfg. / Distribution customers
Job Type: Contract
Pay: $31.00 - $32.00 per hour
Expected hours: 40 per week
Benefits:
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- 21 CFR regulation: 3 years (Preferred)
- SAP: 3 years (Preferred)
- Quality assurance: 5 years (Preferred)
- batch record review: 3 years (Preferred)
- Pharma or medical device or biotech or healthcare industry: 3 years (Preferred)
- CGMP: 3 years (Preferred)
Ability to Commute:
- North Chicago, IL 60064 (Required)
Work Location: In person
Salary : $31 - $32
