Quality Assurance Online Specialist II - Off Shift
: Job Details :

SUMMARY OF POSITION The QA Online Specialist supports all Operations activities (covering 1st, 2nd & 3rd shift operations as assigned, weekend and holiday coverage may be necessary based on business needs), including batch record review, qualification/validation protocol and report review, and quality oversight of the production floor, to ensure delivery against both plant and Quality Assurance (QA) goals and objectives. ORGANIZATION STRUCTUREThe Quality Online Specialist reports to the Manager of Quality Operations.RESPONSIBILITIESPrimary responsibilities of this role include the following:Level I:

Executed Batch Record Review.

Ensure records move through process, to final release, meeting all requirements (both compliance and schedule commitments).

Operations Support.

Keep abreast of any issues within Operations.

Ability to trouble-shoot.

Required off-shift contact & support.

General knowledge of plant operations; Manufacturing, Packaging, Laboratory, Supply Chain, Facility, etc.

Keep abreast of industry regulatory and cGMP trends. Stay informed of FDA, EU and ICH Guidelines.

Additional duties as assigned.

Level II: (In addition to Level I requirements)

Investigation system support / Perform RCA (Root Cause Analysis).

Strong knowledge of at least one plant operation; Manufacturing and Packaging.

QUALIFICATIONSLevel I:

Associate or Bachelor of Science in Chemistry, Life Science, Engineering or combination of training, education, and experience that is equivalent.

A minimum of 1 - 3 years pharmaceutical industry experience, including experience in Quality Assurance/Quality Control.

Working knowledge of Microsoft Office applications is required.

Excellent communication skills with colleagues, peers, and outside clients.

Attention to detail and capable of working independently.

Level II: (In addition to Level I requirements)

A minimum of 3 - 5 years pharmaceutical industry experience, including experience in Quality Assurance.

Strong written and verbal communication skills

Capable of working independently based on regulatory requirements and corporate goals.

GMP DECISION-MAKING AUTHORITYLevel I: Has authority to review and comment on GMP documentation.Level II: (In addition to Level I requirements)Has authority to approve GMP documentation as designated by Quality Leadership, as needed. This role will offer a base salary that is commensurate with experience and demonstrated skills in the $70,000-$75,000.00 range. An Equal Opportunity Employer, including disability/vets.