Quality Control Compliance Specialist
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Quality Control Compliance Specialist
- Location: Harmans, MD
- Industry: Pharmaceutical
- Hours: M-F- Shift: 8am - 5pm
- Salary: $36.04hr (Paid Weekly - Benefits Available)
- Employment Type: 6 month Contract
This role is responsible for supporting the Quality Control team, including EM Microbiology authoring protocols and SOP, conduct training, change control and critical facilities/utility qualifications, create and review environmental monitoring sampling plans, review alert and action limits, support programs such Environmental Monitoring and compendial testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
Supports the Environmental Monitoring program:
Author and Review Environmental Monitoring protocols and SOPs.
Revise SOPs that have Action and Alert limits to align with new settings
Review Sampling plans for validation and routine
Review Alert and Action levels for BWI Harmans suites based on first year data
Create sample matrix with sample requirements for EMPQ of additional clean room suites at new BWI Harmans facility
Complete maps to identify sample locations for all EM sample types for additional clean room suites at BWI Harmans facility
Attend project meetings; fostering teamwork and project collaboration; communicating effectively with focus on problem-solving; other Quality- related tasks as needed.
Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
Conducts training on applicable SOPs
Participate in site quality and process improvement initiatives. Represent QC Microbiology on site project teams.
Other duties as assigned
SKILLS & TECHNICAL EXPERTISE:
Experience with Good Manufacturing Practices (GMPs)
Experience with ICH Guidelines / EU GMPs
Ability to quickly learn and navigate electronic systems
Able to work in a team setting and independently under minimum supervision
Ability to work in fast paced environment
Creative individual with excellent trouble shooting skills
Requires the ability to produce results in with limited timelines, Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry
Minimum of a B.S. in a Life Sciences discipline
+8 years experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory
1-2 years experience in Quality Control / Compliance function
Experience with Environmental Monitoring Programs and microbial testing
Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
Exposure to Lean Operational Excellence highly desirable
Experience working in electronic systems such as LIMS, EDMS, ERP desirable"
MEASUREMENT OF PERFORMANCE:
Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Dependable and can work with minimal supervision on scheduled tasks
Timeliness and accuracy in completion of projects and documentation (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to Company policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions