Quality Assurance Associate III:
Requires knowledge and the application of basic scientific and regulatory principles utilized to solve operational, as well as routine tasks in the quality assurance/quality control departments supporting Phase I/II GMP manufacturing of bulk biologics. Experience supporting Federal government contracts is a plus. Mature professional capable of independent work at times. Creative individual with excellent trouble shooting skills. Requires the ability to produce results in a fast-paced environment to meet client deadlines. Shift work and/or weekend work may be required at times.
Minimum Knowledge and Skills Required
- High School Diploma and >7 years experience in the sciences working in a Quality Assurance/Quality Control setting. Experience with batch record review and lot disposition, deviation and failure investigation resolution, CAPA maintenance as well as supplier audits and review of general GMP documentation
- Or Bachelor’s degree in the sciences with >4 years experience Or
Master’s degree with >2 years of experience as described above.
Major Duties, Responsibilities and Communication
- Decisions or recommendations consistently result in favorable project results and client satisfaction.
- Is involved with the quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials.
- Will work with clients during initial and subsequent manufacturing campaigns.
- Conducts review of batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate ensuring appropriate closure and dispositions lot.
- Conducts audits of suppliers/contract test laboratories to ensure compliance with applicable regulations and Paragon policies and procedures.
- Assists in the management/control of raw materials/supplies.
- Reviews facility GMP documentation such as temperature charts, logbooks, cleanings, calibration and maintenance records, etc.
- Maintains databases used for tracking various GMP manufacturing associated support activities.
- Assists with the generation and/or revision of GMP documentation such as standard operating procedures, material specifications, and master production records.
- May be called upon to review validation protocols (generation and executed) as related to a specific manufacturing process.
- May participate in regulatory (FDA, EMEA) and client audits/inspections of Paragon and the facility.
- Assists with performing internal audits.
- Works under general supervision to meet project goals.
- Works closely with Manufacturing, Facilities and Quality Control staff to resolve quality issues with regards to the facility and products manufactured.
- Will work closely with various departments at Paragon and offer assistance as needed.`
Measurement of Performance
- Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team.
- Timeliness and accuracy in completion of projects and paperwork. (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. (knowledge/problem solving)
- Exercises good judgment in dealing with operational problems. (knowledge/problem solving)
- Understanding of theory, rationale behind tasks performed. (knowledge)
- Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs.
- Ability to succeed in a team oriented environment under very dynamic (changing) conditions.
**Preference will be given to candidates with experience in direct support of federal government contracts.
Interested parties are encouraged to mail their CV with a cover letter to:
Paragon Bioservices, Inc.
Attn: Human Resources
801 W Baltimore St
Baltimore, MD 21201