Spectraforce Technologies
Position Title: Associate Data Reviewer
Work Location: Worcester, MA, 01604
Assignment Duration: 6 Months
Work Arrangement: 100% Onsite
Position Summary
The
Associate Data Reviewer
will support the QA Data Review team within a fast-paced GMP environment. The role focuses on reviewing and archiving data related to raw materials, environmental monitoring, in-process samples, final bulk, stability, and validation activities.
This position includes both administrative and technical responsibilities, with initial emphasis on
archiving
and potential progression to
data review
tasks.
Background & Context Part of the QA Data Review Group at the Worcester site. Responsibilities include reviewing validation, raw material, microbiology, analytical, bulk, and release testing data. The team ensures
final data review and authorization
prior to release. Two profiles are sought: Administrative archiving-focused. Analytical and/or microbiology data review-focused.
Key Responsibilities
Archive data in the
RIMS system . Perform routine laboratory test data reviews, including
On-the-Floor
and
Off-the-Floor
reviews for low-complexity methods. Maintain compliance with
GMP standards , laboratory records, procedures, and systems. Ensure a
safe work environment
for self and colleagues. Manage
administrative tasks
such as logbook control, scanning, and filing of data. Accept responsibility for timely completion of assigned tasks. Collaborate effectively to maintain a positive and productive team atmosphere. Support training of other employees through
hands-on demonstration
(not management of training delivery).
Qualifications & Experience
Education: Bachelor's degree, OR High School Diploma with
5+ years
of combined experience in manufacturing, QA, or QC within pharmaceutical/biologics, OR Master's degree with
1-2 years
of relevant industry experience (not considered overqualified).
Strong attention to detail with excellent organizational and time management skills. Preferred Experience:
QC lab data review and familiarity with biologics production. Laboratory experience to support data review understanding. Knowledge of large, matrixed organizational environments. Familiarity with
RIMS
(training available),
Empower
for analytical data review, and sample management systems.
Physical Requirement: Ability to lift up to
10 pounds
independently.
Work Location: Worcester, MA, 01604
Assignment Duration: 6 Months
Work Arrangement: 100% Onsite
Position Summary
The
Associate Data Reviewer
will support the QA Data Review team within a fast-paced GMP environment. The role focuses on reviewing and archiving data related to raw materials, environmental monitoring, in-process samples, final bulk, stability, and validation activities.
This position includes both administrative and technical responsibilities, with initial emphasis on
archiving
and potential progression to
data review
tasks.
Background & Context Part of the QA Data Review Group at the Worcester site. Responsibilities include reviewing validation, raw material, microbiology, analytical, bulk, and release testing data. The team ensures
final data review and authorization
prior to release. Two profiles are sought: Administrative archiving-focused. Analytical and/or microbiology data review-focused.
Key Responsibilities
Archive data in the
RIMS system . Perform routine laboratory test data reviews, including
On-the-Floor
and
Off-the-Floor
reviews for low-complexity methods. Maintain compliance with
GMP standards , laboratory records, procedures, and systems. Ensure a
safe work environment
for self and colleagues. Manage
administrative tasks
such as logbook control, scanning, and filing of data. Accept responsibility for timely completion of assigned tasks. Collaborate effectively to maintain a positive and productive team atmosphere. Support training of other employees through
hands-on demonstration
(not management of training delivery).
Qualifications & Experience
Education: Bachelor's degree, OR High School Diploma with
5+ years
of combined experience in manufacturing, QA, or QC within pharmaceutical/biologics, OR Master's degree with
1-2 years
of relevant industry experience (not considered overqualified).
Strong attention to detail with excellent organizational and time management skills. Preferred Experience:
QC lab data review and familiarity with biologics production. Laboratory experience to support data review understanding. Knowledge of large, matrixed organizational environments. Familiarity with
RIMS
(training available),
Empower
for analytical data review, and sample management systems.
Physical Requirement: Ability to lift up to
10 pounds
independently.