Quality Assurance Associate III

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

lbutler@paragonbioservices.com