Sr. Quality Assurance Specialist Job at Planet Group, Waltham, MA

NnpTSTZUZEVhdHB5TUdKSzRmcEN5NlpmOFE9PQ==
  • Planet Group
  • Waltham, MA

Job Description


Target PR Range: 47-57/hr
*Depending on experience

Sr. Quality Assurance Specialist
Waltham, MA

The Senior Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notifications. This function also is the primary person to audit batch records for product manufactured by TPM plants and enter required batch documentation into the EDMS and prepare product for disposition.

Responsibilities
· Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
· Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.
· Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
· Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.

Qualifications
· Bachelor’s degree preferably in Engineering or Science
· Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
· Knowledge of GMP regulations and standards affecting pharmaceutical products
· Comprehensive knowledge and application of business and quality concepts
· Strong analytical skills and attention to detail
· Change plan, Exception Reports, SAP and LRMS experience is highly preferred
· Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
· Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization

Job Tags

Contract work, Local area,

Similar Jobs

Lifeline Home Health

Skilled Nurse RN Job at Lifeline Home Health

The staff nurse is a registered professional nurse who administers skilled nursing care to patients. Each staff nurse performs nursing services for residents within a specific area. These services are performed in accordance with the nurse practice act/scope of practice...

The University of Mississippi

Teaching Assistant Job at The University of Mississippi

 ...developmentally appropriate play based education for the children they teach. Willie Price is accredited by NAEYC and licensed by the...  ...Min Mid Max $29,120$36,400$43,680 Role Summary Assists with curriculum preparation, classroom facilitation, and student... 

Reynolds EmpowerHome Team

Real Estate Listing Agent Job at Reynolds EmpowerHome Team

 ...to our reverse prospecting lead gen system and powerhouse inside sales team, were generating 1,000+ seller leads every week and...  ... Meet with motivated sellers to help them list and sell their home with confidence Stay in regular contact and build relationships... 

Wells Fargo

Lead Tech Bus Systems Consultant (SACM) Job at Wells Fargo

 ...role:**Wells Fargo is seeking a Lead Technology Business Systems Consultant with strong Cloud experience.This position is within the...  ...will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin... 

Hemlock Restoration Initiative

AmeriCorps Stewardship and Volunteer Engagement Associate Job at Hemlock Restoration Initiative

 ...Summary of Position: The purpose of the AmeriCorps HRI Stewardship and Volunteer Engagement Associate position is to ensure ongoing protection of eastern and Carolina hemlock trees from HWA by increasing the capacity of HRI partner agencies to treat trees using chemical...