Overview
Quality Assurance/Quality Improvement Coordinator Jobs in Lillington, NC at First Choice Community Health Centers
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
The role:
The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
This position supports Weekend 1st Shift. The Weekend Shift is responsible for weekends and Holidays in addition to flexible workdays on Thursday/Friday or Monday/Tuesday, respectively. The hours are from 0630 to 1730 on Saturday/Sunday and 0630 to 1530 on Thursday/Friday or Monday/Tuesday, as applicable. The work schedule is 36 hours and is considered full-time. The shift may be flexible based on business needs.
The responsibilities:
Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety
In-process review of records (batch records and other documents involved in aseptic processing of drug product) to ensure they are complete, accurate, and compliant with current Good Manufacturing Practices (cGMP) requirements
Reports errors, deficiencies, discrepancies and observations to management and provide direction to halt operations if/when product safety is or may be compromised
Performs quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight
Works in collaboration with management teams to prepare for internal and external audits and assists with timely closure of audit observations and corrective and preventative action responses (CAPAs)
Initiates and authors nonconformance reports (NCRs) and CAPAs
Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods
Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement
Ensures that SOPs are current and effective, and that staff performs routine tasks according to SOP through direct observation
Desirable qualifications:
BS degree (preferred science discipline), or AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required
Intermediate (or higher) proficiency in MS Office Suite (Word, Excel, and Outlook)
Ability to use and understand enterprise software (i.e., JDE)
Physical / Safety Requirements:
Must wear appropriate PPE as required for various manufacturing areas
Must be able to gown qualify for Grade A/B areas
Duties may require overtime work, including nights and weekends
Position requires standing for long hours, but may require sitting for periods of time
In return, you’ll be eligible for [1]:
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[1] Current benefit offerings are in effect through 12/31/24
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra’s approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
Title: Quality Assurance/Quality Improvement Coordinator
Company: First Choice Community Health Centers
Location: Lillington, NC
